At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose The purpose of the Senior Associate/Principal Associate – Global Medicines Quality Organisation (GMQO) representative is to support the development and implementation of the strategy for quality systems and activities to support business goals and objectives. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and other areas. This Quality role will support the Clinical Trial Foundations (CTF) team in the strategy and development of contemporary clinical trial processes, technologies, information, and capabilities and in shaping external policy and guidance to speed the delivery of medicines to patients globally. CTF assist with functional area business and Tech@Lilly processes related to the development and lifecycle management of these systems, including data information & migration services. Primary Responsibilities This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. 1. Implement and Manage Quality Systems Contribute to the development of CTF procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents. Recommends new quality system documents or changes to existing quality system documents where applicable. Advise on appropriate training for implementation and documentation. Provide consultation on the interpretation and practical application of external requirements, standards, and procedures. Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed. Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary. Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps. Complete self-inspections and drive improvements that are meaningful and actionable. Ensure local implementation of the quality systems as necessary. Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned. 2. Provide Quality Oversight for business area(s) Monitor for compliance to quality system documents. Anticipates gaps and proactively proposes solutions. Communicates and escalates to management as appropriate. Ensure implementation of Quality Plan(s) as necessary. Monitor progress of actions. Provide updates to quality and business owners. Seek and implement simplification and process improvement. Coordinate quality improvement initiatives. Review metrics and trending to improve processes and compliance, as assigned. Compile compliance metrics and maintain metrics. Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions. Monitor completion of deviations, change controls, CAPA, audit responses. 3. Audits and Inspections Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses). Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions). Ensure completion of audit corrective action plans and timely resolution. Leads and/or supports readiness activities in collaboration with business partners. 4. Partnership with other area(s) Functions as the initial point of consultation for business areas on quality related questions. Partners with the business area(s) to strengthen and ensure appropriate quality controls are in place. Shares key learning to drive simplification and replicate best practices. Collaborates with other quality groups as appropriate and develops quality network. Establishes good working relationships with assigned business area(s). Actively participates in team, business and quality related meetings. Supports issue resolution including escalation. Utilize a risk-based approach in guiding business areas. Support key projects as assigned. Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned. Minimum Qualification Requirements Bachelor’s Degree in a science/technology/health care related field or equivalent work experience. Demonstrated ability to apply quality systems within a regulated work environment. Effective project and time management skills. Demonstrated ability to communicate effectively, both written and verbal, and to influence others. Demonstrated ability to prioritize and handle multiple concurrent tasks. Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies. Strong interpersonal skills with demonstrated flexibility in varying environments/geographies. Effective organization/self-management skills. Other Information/Additional Preferences Master’s degree or above. Five years’ experience or more in quality and/or clinical trial processes and technology. Knowledge of quality systems. Knowledge of business systems support. Ability to work independently and as part of a team. Demonstrated ability to work in a global environment. #J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. We are the Global Pharmacokinetics/Pharmacodynamics (PK/PD) and Pharmacometrics Department at Lilly, and we're looking for talent to join our newly formed Operational Team. We work with the goal of identifying the right dose of the right drug for the right patient and living the model-informed drug discovery and development (MIDD) paradigm. The PK/PD Operations Team will work to streamline, manage, and oversee departmental deliverables. As a PK/PD Regulatory Activities Coordinator, you will be responsible for assisting with PKPD regulatory tasks related to the submission of medicines to global regulatory authorities. You will apply your knowledge of global regulatory guidelines, clinical trial data reporting (early and late phase), and PK/PD knowledge to advise and support PKPD scientists on required deliverables. You will work closely with PK/PD scientists and cross-functional teams to oversee key PK/PD deliverables, ensuring high quality and on-time delivery. We seek dynamic, energetic, curious, and collaborative data scientists, project managers, or clinical operations specialists with a passion for operations, ready to engage and work on life-changing therapies for patients. We are passionate about making an impact in the lives of our patients and pushing the boundaries of science. Consider joining Team Lilly in Cork to contribute to Lilly’s drug discovery and development efforts. Primary Responsibilities: Regulatory Expertise: Familiarity with global regulatory requirements for each region. Advise PK/PD Scientists on requirements to support submission deliverables. Assist on packaging submission deliverables and regulatory responses. Coordinate PK/PD deliverables with Global Regulatory Affairs Regulatory Scientists. Develop critical product registration timelines and electronic submission structure and content requirements. PK/PD scientific and technical knowledge: Understanding of PK/PD analyses, data reporting and dataset requirements, and common technical documents for submissions. Collaborate with data management teams to ensure accurate collection, processing, delivery and analysis of PK/PD data, adhering to established standards. Contribute to process improvement initiatives to enhance efficiency, leveraging best practices, and innovative approaches. Collaborate with cross-functional teams to deliver submission documents. Minimum Requirements: BSc in relevant scientific field, such as biological/pharmaceutical sciences, chemistry, engineering, statistics, data science or health-related discipline. Understanding of Pharmacokinetics/Pharmacodynamics principles. Regulatory experience in a pharmaceutical or biotech setting. Additional skills/preferences criteria: Knowledge of regulatory and compliance guidelines. Understanding of clinical pharmacology (PK, PD and pharmacometrics) principles. Knowledge of Clinical Quality work processes and GCP compliance. Excellent organizational and time management skills. Proven ability to work independently and adapt to evolving priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders. #J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Position Brand Description: The Senior Principle Process Automation Engineer provides technical leadership and expertise for automation support of manufacturing operations in accordance with appropriate Good Manufacturing Practices (GMP) and safety guidelines. This leadership role includes mentoring Process Automation Engineers on process control system configuration, change control implementation, deviation investigation, Computer System Validation (CSV) consultation, data mining and analysis, and routine automation computer system support activities. This role provides engineering solutions to the business, utilizes first principles in delivery of these solutions, provides off-hours automation control system support as needed, and can recommend new control strategies for the various processes utilized in pharmaceutical manufacturing operations. Key Objectives/Deliverables: Provide technical guidance and mentorship to the team members Foster a collaborative and innovative work environment Design and develop automation solutions for biopharmaceutical manufacturing processes Collaborate with cross functional teams to ensure alignment with site and project requirements Implement best practices for system reliability, scalability, and efficiency Program and configure automation systems, including but not limited to Distributed Control Systems (DCS), PLCs, HMIs and SCADA solutions Create automation related change controls Design and implement automation changes to the manufacturing process Execute CSV activities Investigate automation related deviations and other deviations Identify opportunities for process optimization and continuous improvement Provide Process Support: Troubleshoot automation computer system hardware Provide off-hours automation control system support Provide technical support for automation control system platforms and/or process information systems (e.g., data historians) Execute all work in a manner consistent with GMP and Lilly policies, procedures, and standards Perform data mining and analysis to monitor the performance and identify improvements in the manufacturing process (e.g., nuisance alarm reduction, control loop tuning, etc.) Perform automation computer system support activities (e.g., system backups, performance monitoring, password maintenance, etc.) Diagnose and resolve complex automation system issues Complete all work in a safe manner and ensure the safety of others Assist in regulatory audits/ internal Lilly Compliance audits Provide Engineering Solutions to the Business: Design and deliver automation for new process units Utilize ANSI/ISA-88 standard for batch process control along with engineering first principles in the delivery of automation solutions Understanding of S88 and S95 design considerations and integration Provide automation technical leadership and project management for engineering projects Provide oversight of contractors assisting in the delivery of automation solutions Provide Recommendations on New Control Strategies / Technologies: Provide thought leadership in the process control space Research and maintain familiarity with various control strategies/technologies Research and maintain familiarity with chemical processes utilized in pharmaceutical manufacturing Assess and maintain metrics for the efficiency and effectiveness of existing process control systems Develop continuous improvement initiatives for process control systems Basic Requirements: Ability to configure and troubleshoot automation control systems Hands on knowledge of DCS (e.g Delta V) systems, PLCs/HMIs (e.g Siemens) and related support systems, Building Automation Systems (e.g Siemens) and historians (e.g Aveva/ OSI PI) Ability to mentor and provide technical expertise to influence decision makers on process and automation topics Teamwork and interpersonal skills Good written and oral communication skills Proficient in Microsoft Office applications including word, excel, PowerPoint, visio and planner/ project Attention to detail Additional Preferences: Previous experience with change control and deviation processes Previous experience (7+ years) configuring and troubleshooting automation control systems Previous experience (2+ years) mentoring others on automation topics Previous experience (2+ years) working in a regulated environment Knowledge of Manufacturing Execution Systems including Syncade Knowledge of automated storage and retrieval systems for warehousing logistics management Knowledge of project management Education Requirements: Degree in Chemical Engineering, Computer Science, Electronic Engineering or qualifications in other relevant discipline with appropriate experience Other Information: Mentor specialists and other engineers in technical and professional development Perform tasks in manufacturing and laboratory areas which require an individual to wear appropriate Personal Protective Equipment (PPE) The normal schedule for this position is Monday-Friday, 8 hours per day. However, emergency situations may require additional support beyond this normal schedule The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities specifically not described in the job description. As always, supervision should be consulted regarding actual job responsibilities and any related duties that may be required for the position. #J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Implement and Manage Quality Systems Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents. Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned. Recommends new quality system documents or changes to existing quality system documents where applicable. Advise on appropriate training for implementation and documentation. Provide consultation on the interpretation and practical application of external requirements, standards, and procedures. Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed. Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary. Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps. Complete self-inspections and drive improvements that are meaningful and actionable Ensure local implementation of the quality systems as necessary. Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned. Provide Quality Oversight for business area(s) Monitor for compliance to quality system documents. Anticipates gaps and proactively proposes solutions. Communicates and escalates to management as appropriate. Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions. Provide updates to quality and business owners. Seek and implement simplification and process improvement. Coordinate quality improvement initiatives. Review metrics and trending to improve processes and compliance, as assigned. Compile compliance metrics and maintain metrics process (for example, periodic report metrics). Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions (for example, PRAC assessment reports). Monitor completion of deviations, change controls, CAPA, audit responses Audits and Inspections Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses). Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions) Ensure completion of audit corrective action plans and timely resolution. Leads and/or supports readiness activities in collaboration with business partners. Partnership with other area(s) Functions as the initial point of consultation for business areas on quality related questions. Partners with the business area(s) to strengthen and ensure appropriate quality controls are in place. Shares key learning to drive simplification and replicate best practices Collaborates with other quality groups as appropriate and develops quality network. Establishes good working relationships with assigned business area(s). Actively participates in team, business and quality related meetings. Supports issue resolution including escalation. Utilize a risk-based approach in guiding business areas. Support key projects as assigned. Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable. Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned. Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures. Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality. Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems. Minimum Qualification Requirements Bachelor’s Degree in a science/technology/health care related field or equivalent work experience Demonstrated ability to apply quality systems within a regulated work environment Effective project and time management skills Demonstrated ability to communicate effectively, both written and verbal, and to influence others Demonstrated ability to prioritize and handle multiple concurrent tasks Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies Strong interpersonal skills with demonstrated flexibility in varying environments/geographies Effective organization/self-management skills Other Information/Additional Preferences Experience in a quality control/quality assurance role Experience in defined functional business areas, for example, medical writing, regulatory affairs, or clinical trial management. Knowledge of quality systems Ability to work independently and as part of a team Demonstrated ability to work in a global environment #J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials, and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, and on-site parking. In-house People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity, and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities, and gender, with four pillars: EnAble, Age & Culture, LGBTQ+, and GIN-Gender Inclusion Network. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Job Description The Trial Capabilities Team provides clinical trial capabilities in support of clinical development. The Associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and closeout. The Associate is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, and activities related to clinical finance, records management, and site training. The Associate will ensure inspection readiness through a complete, accurate, and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences. Responsibilities: Clinical Trial Capabilities Responsibilities Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities. Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out. Identify, communicate, and resolve issues. Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems. Leverage previous site/review board engagements to efficiently drive new work. Populate internal systems to ensure accuracy of trial/site performance. Understand and comply with procurements, legal and financial requirements and procedures. Populate Trial Master Files and libraries for future reference. Provide feedback and shared learning for continuous improvement. Leverage trial prioritization. Anticipate and monitor dynamically changing priorities. Basic Qualifications/Requirements: Bachelor’s degree preferably in a scientific or health-related field, two years clinical research experience or relevant experience preferred. Understanding of the overall clinical development paradigm and the importance of efficient site initiation. Applied knowledge of project management processes and skills. Appreciation of/experience in a compliance-driven environment. Ability to learn and comply with financial and legal guidelines and policies (budget and contract). Language capabilities in English and Romanian. Additional Skills/Preferences: Effective communication, negotiation, and problem-solving skills. Self-management and organizational skills. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form https://careers.lilly.com/us/en/workplace-accommodation for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. #WeAreLilly #J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Main Purpose and Objectives of Position : The Lead-Maintenance Planner is responsible for technically planning, scheduling (where applicable), coordinating and overseeing all aspects of maintenance activities within their area of responsibility. It will be the link between the different workstreams in the area relating to maintenance activities. Sr. Expert Specialist-Maintenance Planner (SM) is the Lilly point of contact for the individual crews assigned to those areas. Lilly has a requirement for people with both electrical and instrumentation (E&I) and mechanical disciplines. In addition, Sr. Expert Specialist-Maintenance Planner (SM) is responsible for controlling the maintenance work within the Computerized Maintenance Management System (CMMS) and ensuring activities are carried out, recorded and ready for inspection by external and internal regulatory auditors always. Key Responsibilities : In line with the above, the following are typically the key tasks that would be expected of the role: Ensure all maintenance activities are carried out in a safe, timely and compliant manner in line with the Lilly LOTO system utilizing TOF. Participate in continuous improvement & lean 5S initiatives. Be the Point of contact for Safety & Quality related questions from craft. Be an advocate for Safety & Quality standards within the maintenance group, promoting and enforcing standards in all work completed. Troubleshoot maintenance issues within area of responsibility. Own the planning and scheduling (where applicable) of preventive and corrective maintenance activities to ensure that all preventive & corrective maintenance activities are completed as scheduled in GMARS (the CMMS) to meet Maintenance metrics requirements. Planning and documenting how work is to be completed. Ensuring spare parts are available & liaise with engineering stores. Co-ordinate the various craft disciplines and vendors to execute Maintenance activities to the highest standards & per site SOP’s. Ensure all work is documented appropriately following ALCOA+ principles. Updating of job plans to ensure accuracy. Schedule, chair & attend meetings to ensure maintenance activities are appropriately scheduled. Be the technical adviser for area of responsibility and escalate issues appropriately. Flexibility to support other areas within the Maintenance team & participate in Project and best practice initiatives within the Maintenance team. Investigate failures and propose solutions to prevent reoccurrence. First point of contact for craft personnel to troubleshoot issues/queries on the CMMS. Manage craft allocation to respond to changing priorities. Pre-Requisites: 2+ years pharmaceutical/biotech industry experience in a maintenance role. B-eng advantageous. Educational Requirements: FETAC level 6 or equivalent in either an E&I or mechanical discipline B-Eng. advantageous. Key Attributes : Strong interpersonal skills Recent maintenance planning experience is an advantage. Any further education in an engineering related discipline is an advantage. Knowledge of Pharmaceutical manufacturing processes is an advantage. Strong written and verbal communication skills Ability to work on own initiative. Ability to work as part of a team ‘Follow the work’ Ability to respond quickly and proactively to changing priorities. #J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. In-house People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Note: We currently have an opening in both our Publications and Regulatory teams. Purpose: Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly. The Senior Manager, Global Scientific Communications (GSC) is responsible for managing a book of work through capacity and personnel management, staff recruitment and development, business planning, and cross-functional communication. The Senior Manager will be responsible for working with cross-functional, multidisciplinary teams to facilitate the delivery of regulatory and/or publication documents. The Senior Manager will draw upon information from multiple internal and external sources to lead and provide technical coaching to the publication team to ensure the effective dissemination of scientific information and the delivery of the portfolio. The Senior Manager will collaborate and influence teams and work closely across GSC to ensure best practices across the function. The Senior Manager will be responsible for developing scientific content for deliverables as needed. Primary Responsibilities: Responsible/accountable for management/delivery of overall book of work for assigned area. Develops and executes sourcing plans in partnership with GSC leads to ensure seamless delivery of asset plan and priorities. Collaborates with function, capability, and site leadership to ensure alignment of business planning and operations. Coordinates across and develops synergies with therapeutic areas, phases of development, and geographies. Adjusts work plan based on shifting priorities using effective change control. Leads and directs internal and external team members in achieving team goals. Identifies and resolves issues impacting delivery of work. Conceives and implements new and efficient ways to accomplish goals. Partners in the selection process and may manage relationship for preferred vendors. Regularly reports results of team activities/metrics to leadership and stakeholders. Manage audit readiness, quality, and compliance to ensure deliverables are accurate, transparent, of high quality, and in compliance with internal/external guidance/regulation. People Management and Development: Recruits, develops, and retains a strategic and operationally capable workforce skilled and knowledgeable in scientific communications. Effectively creates and manages an agile organization that continuously meets the needs of a changing portfolio. Builds an organizational culture aligned with Team Lilly – inclusion, innovation, acceleration, delivery, integrity, excellence, and respect for people. Develops staff who demonstrate expertise in drug development, therapeutic area science, strategic thinking, project management, and cross-functional leadership. Provide input on employee development, talent assessment, and succession planning activities. Develops an organizational talent base that demonstrates judgment-based decision making. Provides guidance, training, and supervision to personnel. Appropriately manage the workload of direct reports; monitor project timelines and quality, and communicate priorities to direct reports. Provide technical support and guidance to direct reports as needed. Evaluates performance by reviewing documents and attending publication team meetings and recommends developmental actions for all assigned staff. Ensure all direct reports are compliant with company policies, procedures and regulations. Document Preparation, Development and Finalization: Develop scientific content for deliverables as needed per the responsibilities covered in the job description for Scientific Communications Associate; the percentage contribution of these responsibilities will vary according to the need of the business. Subject Matter Expert/ Organizational effectiveness: Leads development of new and emerging capabilities to support the effectiveness of GSC. Functions as expert on document strategy, planning and execution, and industry standards and guidelines. Shares expertise with others. In partnership with others, develop, implement, and update Lilly policies, procedures, training, and tools that are compliant with industry guidelines. Minimum Qualification Requirements: Master’s degree in a scientific, health, communications, technology, health outcomes, or public health related field. 3 years’ experience medical communication / pharmaceutical industry. 2 years’ experience in leading/managing a key part of portfolio or business process. Experience leading others, including relationship and team building, setting expectations, holding others accountable, and technical coaching. Strong scientific communication skills, including extensive experience in writing, reviewing, and publishing scientific materials and the ability to appraise scientific literature and raw data critically. Ability to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills. Successful completion of writing exercise. Other Information/Additional Preferences: Advanced degree (MBBS, MD, PharmD, PhD, MPH). Educational/work background in a health care, medical affairs, clinical development, health outcomes, public health, scientific or medical communications field. Expertise in industry standards and best practices, compliance issues, and regulatory requirements. Strong leadership, problem-solving skills, negotiation/influence/motivation, project management and critical thinking skills with ability to use effectively in a team, cross-functional setting and/or global environment. Clinical pharmacology, therapeutic area or other medical/scientific-specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, endocrine, health outcomes, public health). Experience managing business plans, budgeting and capacity resourcing. Knowledge of scientific, statistical, and research principles and guidelines. Experience in the global environment and an appreciation for global diversity. Knowledge of software/tools used in scientific writing. Experience leading submission or launch activities. Limited travel, including international, up to 10%. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly #J-18808-Ljbffr
Lilly Sr. Scientist, TSMS Process Support - ADN RAMP Team in Limerick, Ireland At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Brand Description: The Lilly Scientist - API/Dry Product Network is rapidly expanding to meet the demand for new products, and several new greenfield sites are under construction and will be starting up in the coming years. The new sites are staffed based on full-scale, steady state production, however additional surge capacity is needed to support the site start-up and help quickly ramp to full capacity rates. The Scientist - ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team that will bring deep manufacturing expertise and will support each site start-up through Operational Excellence knowledge, rapid troubleshooting and problem-solving capability, and surge capacity resources. This unique opportunity will enable team members to work at our new sites, create a larger Lilly network, build and use their technical skills, and learn leadership skills through formal training and on-the-ground experiences. This team will also build strategies to help other new Lilly sites to start up faster, helping to accelerate Lilly’s vision of serving more patients. Success in this challenging role will require supporting the sites through startup, through direct technical execution, coaching next employees, and strong collaboration – and development of the local technical and operational teams to be ready for full operation. The team will directly report through their respective functions but will be coordinated by the Ramp Team Sr. Director. Responsibilities: Support site start-up within TSMS through documentation preparation and review; monitoring of the processes through start-up/validation and ongoing manufacture. Work with the Process Teams in support of start-up of processes – providing hands-on support of documentation preparation, review and approval. Understand the electronic batch record, process flow document (PFD) and validation of the process of process/product being supported. Engage regularly with Molecule Steward to ensure all TSMS documentation is accurate and reflective of new facility. Understand the historic and potential failure modes of the process as part of the Process Team support. Be familiar with site quality systems; change control, deviation reporting, annual product reviews, stability, homogeneity etc. Support where necessary the Process Team on the key quality and operational parameters of the process as determined in the Process Monitoring Plan. Utilize root cause analysis techniques to investigate process issues and deliver robust and sustainable corrective and preventative actions. Document robust and effective deviations post root cause analysis and work with Process Team members to coach and train on effective Technical Writing. Ensure the process remains in a validated state by monitoring the process during the campaign and documenting a review of the process in campaign reports. Lead or contribute to PHRs and Risk Assessments (e.g. FMEA), identifying actions/countermeasures, tracking actions/countermeasures. Act as a mentor/coach to TSMS representatives and other technical support staff. Basic Requirements: BSc Chemistry, Biochemistry or related science field with 3-5 years’ experience in pharmaceutical manufacturing. MSc Chemistry, Biochemistry or science-related field with 3+ years’ experience in pharmaceutical drug substance manufacturing support. Additional Skills/Preferences: Technical depth in manufacturing science and understanding of documentation requirements. Excellent verbal and written communications skills. Strong analytical and problem-solving skills. Collaborative skills with operations, process engineering, QCL and other process team members. Technical knowledge of manufacturing and deviation investigation. Ability to coach others. Ability to influence without authority. Ability to clarify and simplify complex issues. Strong trust building with peers and leaders. Willing to work off-shift hours as needed to support project milestones and training of new employees. Other Information: The ADN RAMP team will support multiple new API/Dry Products sites in various locations (US and OUS). Significant travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $167,200. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). #J-18808-Ljbffr
QA - Supplier/Service Provider Management page is loaded QA - Supplier/Service Provider Management Apply locations Ireland, Limerick time type Full time posted on Posted 2 Days Ago job requisition id R-81646 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction. Main Purpose and Objectives of Position: We are seeking highly motivated, talented Quality Assurance Associates to support our new Biologics Manufacturing Facility. The ideal candidate is an organised and methodical professional who fosters a positive team environment. Provides Quality leadership, direction and governance for materials management. Assures consistent implementation of Quality standards across the quality system for materials management. Manages quality-related matters specific to Materials. Is responsible for approving appropriate quality-related documents. Performs ongoing monitoring that includes: monitoring of quality systems, the self-inspection program, verification of the effective implementation of key GMP programs, and review of systems that impact Product Quality to ensure that they operate in a state of control. Establishment, maintenance and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned. Continue to provide coaching and mentoring to operations personnel and to other QA reps, on the appropriate risk management to provide appropriate and timely solutions to compliance in a business-focused fashion. Key Responsibilities: Develop and implement Quality system for materials management including SOPS, Quality agreements and Risk assessments. Review and approval of change controls, observations deviations, intra company issues associated with the area(s) of responsibility. Reports & escalates critical quality issues to the appropriate level of quality management. Review and approval of other key GMP documents such as GMP standard operating procedures, sampling protocols, receiving instructions. Understand the Monitoring and Maintenance of all aspects of GMP compliance. Participate in quality risk management activities such as FMEA’s. Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in area of responsibility. Communication and education of personnel in GMP requirements and Contribution to the GMP Plan for Materials Management. Assess the impact on product quality of issues associated with materials and consumables. Assurance that the Quality System(s)/Program remains in a validated state and within regulatory commitments. Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program. Support slow moving inventory and product discontinuation initiatives. Liaison between process team and other quality areas. Benchmarking of current and emerging Materials Management initiatives. Ensure the required relevant knowledge and experience/training necessary to fulfil duties is acquired. Basic Requirements: BSc (Hons) in Science, Engineering or Quality related discipline with appropriate experience. Additional Skills/Preferences: Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritization, and organizational skills. Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions. Positive Influence: Demonstrated ability to address issues as they arise and act accordingly. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve. Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organization. Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions. Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations. Decision Making: Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly #J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Brand Description: The Lilly Scientist - API/Dry Product Network is rapidly expanding to meet the demand for new products, and several new greenfield sites are under construction and will be starting up in the coming years. The new sites are staffed based on full-scale, steady state production; however, additional surge capacity is needed to support the site start-up and help quickly ramp to full capacity rates. The Scientist - ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team that will bring deep manufacturing expertise and will support each site start-up through Operational Excellence knowledge, rapid troubleshooting and problem-solving capability, and surge capacity resources. This unique opportunity will enable team members to work at our new sites, create a larger Lilly network, build and use their technical skills, and learn leadership skills through formal training and on-the-ground experiences. This team will also build strategies to help other new Lilly sites to start up faster, helping to accelerate Lilly’s vision of serving more patients. Success in this challenging role will require supporting the sites through startup, through direct technical execution, coaching next employees, and strong collaboration – and development of the local technical and operational teams to be ready for full operation. The team will directly report through their respective functions but will be coordinated by the Ramp Team Sr. Director. Key Objectives/Deliverables: Responsible for the development, implementation and establishing ongoing monitoring of the Contamination Control Strategy (CCS) for new site facilities including but not limited to: Facility /Utility Controls: In collaboration with the New Site CCS team, design, implement, support validation of and maintenance of routine and Batch Specific environmental monitoring (EM) programs. Where necessary, design, implement, support validation of Clean Utilities microbiological monitoring programs. Support aseptic qualification/requalification programs. Liaise with engineering on the New Facility design requirements to support CCS such as but not limited to pressurization cascades, area classification, material, personnel and equipment flows. Material controls: Provide microbiological control strategy support for Raw Materials. Provide the Microbiological Controls to support the Resin Management programs where necessary. Liaise with Quality Assurance to ensure microbiological controls are considered in the application of Vendor Management such as but not limited to approval of GMP Service providers, risk assessment of GMP Consumables and approval of new raw materials. Equipment Controls: Liaise with cleaning validation group on microbial requirements for cleaning validation. Provide Microbiological support to C&Q such as but not limited to commissioning and qualification of cGMP autoclaves and Parts Washers (SOP and COP studies) and steam in place (SIP) systems in Biotech facilities. Provide Microbiological support for process support qualification (PSQ) studies such media challenges, Media and Buffer Hold Time Studies and resin lifetime studies. Liaise with Engineering on filtration requirements to support product specific elements of contamination control strategy. Product Controls: Ensure implementation of the microbiological requirements for the integrated product control strategy. Provide direction on handling of non-conforming results. Support Microbiological trend analysis and metrics reporting as required. Member of the deviation response team for management of suspect Microbiological Contamination events. Provide microbiological support for procedural and batch record updates as required. Stay current with Industry trends and updates to applicable guidelines such as ISO standards and GMP requirements within area of responsibility. Coach and mentor site CCS teams on implementation and maintenance of all CCS programs. Basic Requirements: BSc Microbiology, Biochemistry or related science field with 8-10 years’ experience in pharmaceutical manufacturing. MSc Microbiology, Biochemistry or science-related field with minimum 5 years appropriate industry experience. Additional Skills/Preferences: Deep technical interest and understanding of Contamination Control Strategy. Excellent verbal and written communications skills. Strong analytical and problem-solving skills. Collaborative skills with operations, process engineering, QCL and other process team members. Technical knowledge of microbial and viral product control. Ability to coach others. Ability to influence without authority. Ability to clarify and simplify complex issues. Strong trust building with peers and leaders. Willing to work off-shift hours as needed to support project milestones and training of new employees. Other Information: The Scientist - ADN RAMP team will support multiple new API/Dry Products sites in various locations (US and OUS). Significant travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( here ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $167,200. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly #J-18808-Ljbffr
