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:The lead Specialist QC Esystems role in the Limerick Quality Control Laboratory (QCL) provides technical support for the electronic systems within the laboratory. This role will support the QCL electronic systems project implementation, ensure compliance and operational support of the laboratory electronic systems associated with all testing activities within the QCL function.Specifically, during the startup phase of the Limerick site (2024 to 2026) the Specialist/Lead will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function.Responsibilities:Key Technical SME on the QCL electronic systems including but not limited to LIMS and Empower.Very knowledgeable of general scientific methods in the laboratory and the Esystems that support the laboratory.Works with global functions in the development and delivery of standardized processes and procedures for the electronic systems in QCL.Primary contact for IT, CSV and the Quality department ensuring the QCL Electronic systems are implemented following a development life cycle approach.Provides guidance to the laboratory on the configuration and optimal use of Esystems.Provides end-user support for QCL electronic systems including troubleshooting complex problems at the application layer within their permission level and escalating as appropriate.Configures master data, worksheets, methods and reports (tabular, trend and labels) within the QCL electronic systems.Supports the Authoring/review of key GMP documents such as GMP standard operating procedures, training materials, test methods creation documents, local qualification documents, lab/ equipment/ computer system periodic reviews, annual product reviews, validation master plans etc.Trains other team members on core QC Esystems.Coordinates across business departments and stakeholders, gathering, and supporting the implementation of enhancement requests for the QCL electronic systems.Processes and supports QCL Esystems Change Control requests.Identifies and implements appropriate CAPAs for the QCL Esystems.Leads Audit requests relating to QCL Esystems.Support the collation of QCL and other departmental metrics from the QCL Esystems.Basic Requirements:Hons Degree Qualified – B.Sc. in Chemistry, Microbiology, Information Technology or related discipline, with a minimum of 6 years relevant GMP experience.Additional Skills/Preferences:Safety first approach to all activities.Strong Quality and Data Integrity mindset in a QC environment. Excellent attention to detail.Proficient in English.Technical expertise in Quality Control applications e.g. Lab Vantage, MODA, Empower, NuGenesis, and benchtop applications such as DataPro2, SoftMax Pro.Highly competent in the use of digital solutions for data, equipment and laboratory management.Experience with regulatory inspections.Key Attributes: 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, prioritisation, and organisational 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 take act. 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 organisation.Ability to lead people: 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.Lillydoes 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: The lead Specialist QC Esystems role in the Limerick Quality Control Laboratory (QCL) provides technical support for the electronic systems within the laboratory. This role will support the QCL electronic systems project implementation, ensure compliance and operational support of the laboratory electronic systems associated with all testing activities within the QCL function. Specifically, during the startup phase of the Limerick site (2024 to 2026) the Specialist/Lead will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function. Responsibilities: Key Technical SME on the QCL electronic systems including but not limited to LIMS and Empower. Very knowledgeable of general scientific methods in the laboratory and the Esystems that support the laboratory. Works with global functions in the development and delivery of standardized processes and procedures for the electronic systems in QCL. Primary contact for IT, CSV and the Quality department ensuring the QCL Electronic systems are implemented following a development life cycle approach. Provides guidance to the laboratory on the configuration and optimal use of Esystems. Provides end-user support for QCL electronic systems including troubleshooting complex problems at the application layer within their permission level and escalating as appropriate. Configures master data, worksheets, methods and reports (tabular, trend and labels) within the QCL electronic systems. Supports the Authoring/review of key GMP documents such as GMP standard operating procedures, training materials, test methods creation documents, local qualification documents, lab/ equipment/ computer system periodic reviews, annual product reviews, validation master plans etc. Trains other team members on core QC Esystems. Coordinates across business departments and stakeholders, gathering, and supporting the implementation of enhancement requests for the QCL electronic systems. Processes and supports QCL Esystems Change Control requests. Identifies and implements appropriate CAPAs for the QCL Esystems. Leads Audit requests relating to QCL Esystems. Support the collation of QCL and other departmental metrics from the QCL Esystems. Basic Requirements: Hons Degree Qualified – B.Sc. in Chemistry, Microbiology, Information Technology or related discipline, with a minimum of 6 years relevant GMP experience. Additional Skills/Preferences: Safety first approach to all activities. Strong Quality and Data Integrity mindset in a QC environment. Excellent attention to detail. Proficient in English. Technical expertise in Quality Control applications e.g. Lab Vantage, MODA, Empower, NuGenesis, and benchtop applications such as DataPro2, SoftMax Pro. Highly competent in the use of digital solutions for data, equipment and laboratory management. Experience with regulatory inspections. Key Attributes: 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, prioritisation, and organisational 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 take act. 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 organisation. Ability to lead people: 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. #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. SAP Analyst - Logistics & Supply Chain Reporting To: M&Q IT Associate Director Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Raheen, Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. Main Purpose and Objectives of Position: The role will support the business processes and systems for Lilly’s manufacturing site inbound, internal, and outbound logistic flows. This involves close collaboration with operations groups responsible for planning, procurement, warehouse operations, dispensing operations, production supply, and shipping. The role will provide expertise for a highly integrated set of systems that includes SAP S/4HANA, SAP Extended Warehouse Management (eWM), warehouse automated storage/retrieval systems (ASRS), and Syncade Manufacturing Execution Systems (MES). The scope of the logistics support will include additional solutions beyond these operational systems, like performance metrics, schedule modeling system, data & analytics, etc. Key Duties and Responsibilities: Understand the systems and equipment involved in logistics operations and material control; and the associated data, workflows, and data flows. Understand how these logistics systems and processes integrate with other critical systems like MES (Manufacturing Execution System) and Process Automation. Support the implementation of SAP eWM; develop expertise in the SAP eWM technology and its integration to additional SAP Supply Chain modules. Learn the logistics business processes, scheduling, applications, tools, etc. Work with site business area, IT Architects, MES architects, and Data Analytics architects to implement the Next Gen Warehouse Solutions landscape to meet business needs most effectively. Work with IT groups like Global Services, Global Infrastructure to support delivery of infrastructure for warehouse solutions to our enterprise. Be forward thinking. Monitor industry trends and technical evolution within the Supply Chain systems landscape. Collaborate with business partners to find new value opportunities through technology and to improve the user experience. Participate in cross-functional projects, understanding business impact, evaluating/recommending technical options. Support site implementation activities, integration to other site functions, and site preparation activities. Work with business areas on cross-organizational issues. Promote process improvement and innovation to drive business process optimization. Adhere to corporate computer systems validation policies and procedures. Ability to: Communicate effectively and build relationships cross-functionally. Coordinate, mentor & coach team members. Take initiative to identify and drive improvements. Requirements: Bachelor’s Degree in Information Technology, Computer Science, Engineering or related field (Level 8 or equivalent). 4+ years of experience in manufacturing, preferred in pharmaceutical or other regulated industries. Experience with integrated logistic flow in a manufacturing facility, including prior experience with SAP and MES systems. Knowledge of System Development Life Cycle. cGMP's. Knowledge of Microsoft Office suite of tools. Project Management and leadership skills. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! 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. 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 marking. 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. 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! Purpose: The Expert Specialist provides technical and project administrative support to the Clinical Development Trial Lead (CDTLs) to help enable on-time and on-budget delivery of key tasks during clinical trial execution. The Expert Specialist/ Sr. Expert Specialist supports trial, asset, and portfolio level tasks that may be assigned to a specific asset team(s) or centrally across a Therapeutic Area (TA)/Business Unit (BU). 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 supervision regarding your actual job responsibilities and any related duties that may be required for the position. Clinical Trial Execution: Assist in the management of study budgets including the setup of purchase orders and e-requisitions. Order, track, and ship study supplies, tools, and/or instruments. Track and report Regional/Global enrollment data for ongoing clinical studies. Perform routine study activities per policies/procedures (e.g. Study closeout). Participate in shared learning forums. May assist with other appropriate trial level activities as needed (i.e. coordination of regional and trial project-related meetings, structure of newsletters, uploading minutes to the study collaboration site(s) or eTMFs as appropriate, etc.). Clinical Trial/Submission Documentation: Support and partner with CDTLs and Management to oversee maintenance and inspection readiness of study files (e.g. eTMF, study collaboration sites, etc.) including quality reviews (routine and pre-inspection), associated updates, and indexing. Support backroom for regulatory and mock inspections. Support collection and review of key information to support submission activities (i.e. collecting and verifying accurate information for financial disclosures/1572 and OSI). Establish, maintain, and use appropriate team information repositories (e.g. study collaboration site; eTMF) and maintain project team rosters. Support filing and archiving processes. Clinical Trial Systems Management: Accurately input study timelines and other trial level required fields into clinical trial database, monitors and updates fields as study timelines or other information changes and troubleshoots illogical data. Assist in producing and distributing project status reports. Coordinate with CDTLs and Management to generate regional-level, trial-level and compound-level milestone and budget reports, enrolment reports, and other reports as needed. Minimum Qualification Requirements: Two-year degree or 2 years administrative or technical experience. Computer proficiency and experience using a variety of software packages (e.g., Microsoft Word, Excel, Power Point, Project). Highly Desired Skills: Strong communication skills; able to communicate clearly and succinctly with team members and leadership. Demonstrated ability to work effectively cross-culturally as well as across regions/geographies with strong customer service skills. Strong teamwork and interpersonal skills including demonstrated ability to flex to changing business needs, attention to detail, strong self-management, organizational skills, and problem solving. Ability to maintain confidentiality. #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 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! Clinical Trial Foundations (CTF) CTF, as part of Clinical Design, Delivery & Analytics (CDDA), provides leadership 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 delivers innovative and reliable supplies, systems, processes, and information to enable clinical development and speed medicines to patients. The Associate Director, CTF Process Management Cork is responsible for designing, sustaining, and continuously improving the efficiency and effectiveness of their assigned global processes. The Associate Director applies their technical and process management expertise to effectively manage their assigned processes, ensuring they are compliant, fit-for-purpose, and efficient. Primary Responsibilities Business Process Support Establishes clear understanding of requirements for process change management to assigned processes including clarity of process inputs, outputs and dependencies. Leads project teams through development of process maps, process documentation, and personnel qualification strategies. Partners with Process Owners to ensure processes integrate with the end-to-end clinical development process. Proposes qualification requirements to Process Owners for those individuals who will execute processes. Defines and evaluates metrics to monitor performance of processes making recommendations for improvement. Understands the external environment and changes that may affect their assigned processes and leads the development of action plans. Influences key stakeholders concerning the design, timing and implementation of process changes. Collaborates with other Process Owners, functional leaders, subject matter experts, Quality, Compliance and Legal to define applicable compliance and business requirements. Partners with Process Owners across multiple disciplines to ensure process execution expectations are clear. Engages in coaching and training others to ensure effective implementation and execution of assigned processes. Project Leadership Related to Area of Process Ownership Defines and leads projects that are within their scope of process ownership. Authoritatively represents assigned processes within broader change initiatives. Minimum Requirements Bachelor’s degree preferably in science, health-related field, or equivalent work experience preferred. 5-8 years experience with at least 3 years in medical, quality, clinical drug development, or clinical information flow preferred. Excellent oral and written communication skills. Strong problem-solving skills. Excellent self-management and organizational skills. Strong interpersonal and leadership skills. Flexibility to adjust quickly and effectively to frequent change and altered priorities. Additional Preferences Demonstrated influence with peers and management. Demonstrated ability to lead change for focus area(s). Proven ability to synthesize information from multiple sources and make risk-based decisions. Experienced in drug development and/or pharma project management experience. Understands quality systems and process management. Six Sigma Black Belt or Green Belt experience. Demonstrated ability to collaborate across boundaries and achieve results. Ability to work in a dynamic environment and deal with complexity. Knowledge of regulatory and quality requirements governing clinical development. Strong business insight. 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 for further assistance. 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: The lead Specialist QC Esystems role in the Limerick Quality Control Laboratory (QCL) provides technical support for the electronic systems within the laboratory. This role will support the QCL electronic systems project implementation, ensure compliance and operational support of the laboratory electronic systems associated with all testing activities within the QCL function. Specifically, during the startup phase of the Limerick site (2024 to 2026) the Specialist/Lead will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function. Responsibilities: Key Technical SME on the QCL electronic systems including but not limited to LIMS and Empower. Very knowledgeable of general scientific methods in the laboratory and the Esystems that support the laboratory. Works with global functions in the development and delivery of standardized processes and procedures for the electronic systems in QCL. Primary contact for IT, CSV and the Quality department ensuring the QCL Electronic systems are implemented following a development life cycle approach. Provides guidance to the laboratory on the configuration and optimal use of Esystems. Provides end-user support for QCL electronic systems including troubleshooting complex problems at the application layer within their permission level and escalating as appropriate. Configures master data, worksheets, methods and reports (tabular, trend and labels) within the QCL electronic systems. Supports the Authoring/review of key GMP documents such as GMP standard operating procedures, training materials, test methods creation documents, local qualification documents, lab/ equipment/ computer system periodic reviews, annual product reviews, validation master plans etc. Trains other team members on core QC Esystems. Coordinates across business departments and stakeholders, gathering, and supporting the implementation of enhancement requests for the QCL electronic systems. Processes and supports QCL Esystems Change Control requests. Identifies and implements appropriate CAPAs for the QCL Esystems. Leads Audit requests relating to QCL Esystems. Support the collation of QCL and other departmental metrics from the QCL Esystems. Basic Requirements: Hons Degree Qualified – B.Sc. in Chemistry, Microbiology, Information Technology or related discipline, with a minimum of 6 years relevant GMP experience. Additional Skills/Preferences: Safety first approach to all activities. Strong Quality and Data Integrity mindset in a QC environment. Excellent attention to detail. Proficient in English. Technical expertise in Quality Control applications e.g. Lab Vantage, MODA, Empower, NuGenesis, and benchtop applications such as DataPro2, SoftMax Pro. Highly competent in the use of digital solutions for data, equipment and laboratory management. Experience with regulatory inspections. Key Attributes: 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, prioritisation, and organisational 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 take act. 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 organisation. Ability to lead people: 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. Lillydoes 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. 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. 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. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Purpose: The Trial Capabilities Associate 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 close-out. The associate is responsible for obtaining clinical trial authorizations and ethical approvals and activities related to 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. Clinical Trial 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), 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. 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. Minimum Qualification 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 activation. Applied knowledge of project management processes and skills. Appreciation of / experience in compliance-driven environment. Effective communication, negotiation, and problem solving skills. Self-management and organizational skills. Language Capabilities: English/Dutch and/or French. 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. 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. About Us: Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies. We are seeking a highly motivated and detail-oriented Qualified Person to join our quality assurance team and ensure the highest standards of product quality and compliance. Position Summary: The Qualified Person (QP) plays a pivotal role in ensuring the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. This position is responsible for implementing and executing batch approval and regulatory authorization for the site. The Qualified Person will collaborate with various departments to support the technical agenda and serve as a technical mentor for the site quality assurance teams. This position is based full-time on site in Raheen, Limerick. Key Responsibilities: Technical Leadership Provide Quality leadership, direction, training and governance for the specific area of responsibility. Carry out day to day activities in compliance with site safety policy and procedure. Promote and encourage safe practices and promptly report any safety concerns. Continue to maintain knowledge and experience in line with technical and scientific progress for product(s) of responsibility in alignment with Annex 16 requirements. Communication and education of personnel in GMP requirements and regulations. Quality Monitoring Programs Monitoring of GMP compliance and verification of the effective implementation of key GMP programs and systems by ensuring a regular presence in the area of responsibility. Monitoring of the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures. Document Review/Approval Responsible for approving appropriate quality-related documents. An approval signature confirms that Lilly, GMP and relevant regulatory requirements have been met. As per the requirements of local procedures, review and approval of change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches. As per the requirements of local procedures, review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data and periodic review reports (PRR) and annual product reviews (APR) product quality evaluations. As per the requirements of local procedures, review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents. Familiar with the contents of or else involved in the review/approval of the applicable Quality Agreements. Regulatory Submission & RTQ Support Responsible for issuance of QP declarations where required. Understand the conditions and requirements when a renewed authorisation is necessary and ensure they are complied with. Evaluation and contribution of regulatory information to regulatory documents including review/approval of dossier sections as part of the product submission processes. Batch Approval Ensures manufactured biotech drug substance (DS) batches are certified in accordance with all required regulations and in compliance with IND/CTAs/ manufacturing authorisation/ marketing authorisation. Ensure that biotech drug product batches are tested in compliance with manufacturing & marketing authorisations (BLA/MAAs/ROW CTDs). Is responsible for the final decision associated with batch certification. Ensures that the principles and guidelines of GMP as stated in 2003/94EC, 2001/83EC, 536/2014 (repealing 2001/20/EC), associated EU GMP annexes, (e.g., Annex 13, Annex 16) and current product specification file (PSF) are met. Basic Qualifications: BSc, MSc, or PhD in Biology, Chemistry, Pharmacy, or related discipline. Must be approved by member state as a licensed QP in order to be named on the company licence as a QP. Additional skills/experience: Minimum of 10 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment. Strong understanding and working knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements. Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment. Demonstrated success in influencing without authority. Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership. Ability to communicate effectively with all levels and functions in the organisation. Ability to work on multiple concurrent project initiatives. Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues. #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. What You'll Be Doing: As a Cloud Security Engineer at Lilly on the Security Architecture and Engineering team, you will play a pivotal role in a dynamic environment. Your responsibilities include managing cloud security tools (CNAPP/CSPM), conducting security reviews of cloud accounts and projects, generating proactive guidance, reviewing and creating IaC/policy as code templates, and participating in cloud design discussions. You will also contribute to the development and implementation of cloud security controls, create integrations and automations for cloud security detection and response actions, and collaborate with various stakeholders across the organization. How You'll Succeed: Technical expertise: As a Cloud Security Engineer, you will leverage your deep technical knowledge of cloud ecosystems (AWS or Azure) to implement tailored security solutions and effectively mitigate threats and risks. Problem-solving skills: Adept problem-solving abilities are crucial in quickly identifying and addressing security issues, ensuring the development and delivery of robust cloud security solutions in a timely manner. Collaboration and communication skills: You will actively collaborate with both local and remote team members, playing a pivotal role in defining, designing, and executing cloud security strategies. Excellent communication skills are essential for this role, as you will need to engage with both technical and non-technical audiences. Agility: The ability to quickly adapt to the changing threat landscape and move at the pace of the adversary is critical to success in this role. Knowledge of cloud security trends: This role requires staying abreast of the latest developments in cloud security and integrating these insights into our practices. Balancing security and operational needs: You will balance stringent security guidelines with operational requirements, maintaining the desired corporate security posture while demonstrating empathy and understanding towards the engineering teams' challenges and needs. Key Responsibilities: Manage cloud security tools (CNAPP/CSPM) and implement cloud security controls in a multi-cloud environment (AWS and Azure). Conduct security reviews of cloud accounts and projects, generate proactive guidance, and participate in cloud design discussions. Review IaC/policy as code template proposals and provide recommendations for secure cloud deployments. Develop integrations and automations for cloud security detection and response actions to support the Cyber Defense Operations. Partner with cloud foundation teams, Cyber Defense Operations, Tech@Lilly, business areas, and suppliers to ensure secure cloud adoption and operations. Perform threat analysis and modeling to enable business and technical partners to deliver secure solutions integrated with the SecOps lifecycle. Apply threat modeling and analysis frameworks such as MITRE ATT&CK and STRIDE (or STRIDE-LM) in security practices. Maintain and expand technical knowledge across cloud security concepts and technologies, driving knowledge growth across security domains. Identify technical solutions and drive implementation to support strategic direction, focusing on value, impact, risk mitigation, security controls, privacy controls, detection, response, and quality. Prioritize mitigations in relation to technology upgrades, enhancements, and process improvements within the respective domains of accountability. Your Basic Qualifications: Bachelor's degree in Cyber Security, Computer Science, Information Technology, or related field Or High School Diploma/GED with 4+ years of experience in Cyber Security, Information Technology, or related field. And 2-6 years of demonstrated experience in cloud architecture and engineering, with a focus on AWS or Azure (slight preference for Azure). Additional Skills: Strong understanding of cloud security concepts, services, and logs, including Identity and Access Management, Networking, and Security in a public cloud environment. Experience with cloud security services such as Security Hub, GuardDuty, CloudTrail, Config, VPC Flow Logs, Amazon Inspector, Amazon Detective, Cloud Custodian, Azure Policy, Azure Activity log, Defender for Cloud, Azure Sentinel, or Security Copilot. At least basic proficiency in a programming language (e.g., Python) and some experience with cloud automation and integration using tools such as Lambda, Step Functions, Glue, Azure Functions, Terraform, or CloudFormation. #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 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. 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. 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. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Purpose: The purpose of the Scientist/Sr. Scientist/Principal Scientist (R1-3) role is to provide tactical, and operational direction and support to expediate device related (drug-device delivery systems, medical devices (firmware, hardware, stand alone and embedded software) or diagnostic) registrations, right to operate and maintenance of Lilly’s portfolio by interacting with teams, Affiliates, and regulators. This role will support global registrations, product maintenance, and GRA-Devices; Drug Delivery, Digital Health and Diagnostic department operations. The Scientist utilizes device technical knowledge, regulatory and device expertise to drive internal consistency and influence effective change management. 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 supervision regarding your actual job responsibilities and any related duties that may be required for the position. Regulatory and Scientific Expertise Technical knowledge of drug delivery and/or medical device, including software, systems development science(s) development and lifecycle management. Support evaluation of regulatory impact on proposed delivery systems and/or medical device change management plans. Anticipate and resolve key technical or operational issues that can impact the function or product team. Support regulatory risk – benefit analysis, internal and external audits for regulatory compliance. Demonstrate strong skills in technical and concise writing of Regulatory documents resulting in effective communication and maximizing feedback from regulators. Influence Provide regulatory guidance to product teams and/or affiliates while implementing regulatory strategies that result in successful global product registrations and device maintenance. Exhibit leadership behaviors. Incorporate new regulations, guidance and company positions into GRA-Device processes/guidelines, tools and/or training materials. Support internal policy development and provide internal input on emerging regulations worldwide for device issues. Monitor global regulatory news and provide interpretation and internal communication as appropriate. Support interactions with global Heath Authorities as required, including key ISO and notified body personnel. Lead/Support/Partner Support preparation, review, and finalization of device documents for global clinical trial authorizations (CTA), registration submissions, response to questions and change control activities. Support strategies impacting product submissions across geographies. Proactively identify and resolve device regulatory issues, leveraging internal experts and/or GRA-Devices subject matter expert (SME) and/or mentor. Communicate effectively verbally and in writing to influence within work group/function and with product team. Support the development of corporate positions on, and responses to, proposed agency regulations and guidelines. Participate in forums that share regulatory information across GRA components. Collect and collate GRA-Devices metrics. Support regulatory impact assessments. Serve as electronic data systems SME. Support regulatory intelligence activities. Identify and execute other operational responsibilities. Decision Making Proactively identifies and resolves device regulatory issues. Minimum Qualification Requirements: Bachelor’s degree in a scientific or engineering discipline (e.g. chemistry, biology, biochemistry, pharmacy, engineering or related scientific discipline) Other Requirements: Medical Device or Pharmaceutical industry experience in technical drug and/or device development (3-4 years) Prior experience authoring device submission content Prior regulatory experience (2-3 years) or equivalent combination of technical and regulatory guidance knowledge Demonstrated negotiation and influence skills. Demonstrated strong written, spoken and presentation communication skills Demonstrated attention to detail Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles Other Information/Additional Preferences: English Fluency #J-18808-Ljbffr
