Senior Director, Integrated Supply Planning Ireland - Dublin, Ireland - Cork Manufacturing Operations & Supply Chain Regular Job Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Responsibilities: This position is responsible for developing and directing the overall strategy of the production planning, purchasing, material control, inventory control and shipping/receiving functions. May develop and implement Supply Chain strategy for multi-country regions. Coordinates the activities of department management, and provides direction and assistance on resolution of complex issues, compliance issues and potential problems related to production planning and material management. Makes or recommends appropriate decisions consistent with strategic direction. Ensures that personnel, equipment, material and services are provided as needed to maintain acceptable inventory levels. Implements and maintains material control systems, policies, processes and procedures, ensuring a controlled flow of approved materials timed to meet production requirements. Provides expertise and guidance in establishment and maintenance of the production control system. Serves as liaison between the company and the various governmental agencies. Directly interfaces with regulatory agencies as required. Coordinates interdepartmental activity with Quality Assurance, Manufacturing, Engineering and Contract Administration. Reviews, approves and/or implements changes to controlled documents as needed. Develops and approves new applications based on professional principles and theories, with a view to broader cross-functional implications. Aligns resources, prioritizes strategies, establishes targets, and implements cost-out initiatives with Global demands. Drives SOP process that is integrated with global processes and timelines. May establish standards, policies, and key vendor relationships/ partnerships within the region of responsibility. Basic Requirements: Relevant experience in related field and a BS, BA; OR MA/MBA. Preferred Knowledge / Experience: Deep expertise in predictive analytics and data modeling. Working experience with SAP S/4 HANA. Able to develop complex concepts, techniques, and standards. Able to develop solutions to complex problems which require an in-depth degree of ingenuity, creativity and innovativeness. Challenges are frequently unique and solutions may serve as precedent for future decisions, which affect the entire organization. Recommends organizational objectives and interprets company policies. In-depth expertise in EU and international cGMPs. Able to interpret, execute, and recommend modifications to department policies. Demonstrates effective communication skills and the ability to deal across several multi-national agencies, sites and organizations. #J-18808-Ljbffr
Sr. Manager, Supply Chain - Master Data Management Apply locations Ireland - Cork time type Full time posted on Posted 3 Days Ago job requisition id R0043586 At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Headquartered in Foster City, California, Gilead has operations in North America, Europe, Asia and Australia. Gilead’s therapeutic areas of focus include cancer, HIV/AIDS, COVID-19, liver diseases and inflammation. Role Overview The Master Data Management team is seeking a dynamic and motivated Sr. Manager to lead the planning master data team and effort. Represents the department as a member of a cross-functional project team providing guidance, insight and recommendations relative to the goals and objectives of the function and may be the sole individual responsible for complex programs with global reach. Job Functions Works on problems of a moderately complex scope where analysis of situation or data requires evaluation of identifiable factors. Is responsible for personnel management, selects, develops, and evaluates staff to ensure the efficient operation of the function. Maintains and assists with the implementation of Supply Chain policies, procedures, techniques, standards, and systems. Contributes to the development of complex new concepts, techniques, and standards. Provides planning master data expertise to the team and functional areas to anticipate and identify complex project issues which pose a challenge to achieving strategic goals. Review, assess the impact on supply planning function, and provide inputs as subject matter expertise on item master data change request in Gilead Product Life Management System. Review, collaborate, and modify distribution organization assignment for sellable part numbers in planning system based on demand and supply plan network requirements. Analyze drug products regulatory approval data, manufacturing qualification data and global supply strategy, provide planning segmentation (pool and channel) proposal for assigned drug products, lead regular cross-functional teams review, and manage the creation, maintenance, and audit of global supply chain plan network for assigned drug products. Accountable for Supply Chain Segmentation strategy and its maintenance and integration in both ERP and Planning systems. Maintain master data attributes in Planning system based on business requirements and system data maintenance standard. Being accountable planning master data governance, documentation, maintenance of change, and audit in Planning System. Manage planning master data parameters, planning source network, inventory target levels, and other supply chain master data elements in planning system. Being accountable for new product launch data readiness on time to meet project timeline and quality requirements for assigned drug products. Being accountable for planning master data readiness in each item master lifecycle for assigned drug products. Act as supply chain planning master data liaison for cross-functional or external contacts. May assist in the development of system and improvement data configuration activities/projects, in support of Gilead’s existing and future business plans. Essential Qualifications: Solid relevant experience in related field and a BS or BA; or MA/MBA. Preferred experience: Experience in pharmaceutical operations/cGMP environment highly desirable. Able to develop solutions to a wide range of moderately complex problems, which require the regular use of ingenuity and innovation. Excellent verbal and written communication skills and interpersonal skills. Demonstrates good planning and organizational skills coupled with strong time management skills. Demonstrates strong understanding on how planning system master data is being utilized in daily operation by both planning and execution functions and processes. Has an aptitude for working with computer systems to plan and manage supply chain requirements. Demonstrates strong analytical and problem-solving skills. Demonstrates up-to-date knowledge of business operating systems, distribution requirements planning, production planning and scheduling, Databases and Microsoft applications (e.g., Access, Excel) as relates to business needs. Proficiency in ERP and Planning system software (SAP knowledge is preferred), with emphasis on Operations/Supply Chain functionality. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. #J-18808-Ljbffr
For Current Gilead Employees and Contractors: At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Headquartered in Foster City, California, Gilead has operations in North America, Europe, Asia and Australia. Gilead’s therapeutic areas of focus include cancer, HIV/AIDS, COVID-19, liver diseases and inflammation. Role Overview The Master Data Management Team is looking for a dynamic and motivated manager to be part of the Plant Level Data team. The Plant Master Data team is responsible for ensuring the accuracy, integrity, and consistency of essential data across Gilead’s systems and platforms for the Cork Plant. This position involves overseeing the management and monitoring of critical data for the plant, working with the cross-functional teams responsible for data entry, and ensuring that the requirements and timelines set for the team are met. Responsibilities include: Representing the Plant Data Team cross-functionally on both Plant level and Global platforms. People leadership and team development. Supervision of personnel, including organizing and prioritizing daily tasks and department activity, inclusive of training and documentation. Collaboration with SMEs across the organization to define and support the implementation of data governance strategies. Developing and documenting process standardization, data governance, cleansing, and data maintenance in line with data strategy goals. Works on problems ranging from semi-routine to moderately complex in scope, where analysis of situations or data requires in-depth evaluation of various factors, good judgment is required in resolving problems and making routine recommendations. Exercises judgment within well-defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Works on more complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences – more future-oriented/preventive analysis to proactively manage quality risks. Implements critical/high impact assurance systems to proactively improve process performance. Participation in collaborative projects where required, interacting with internal and external resources as required. Basic Qualifications: Solid relevant experience with BS/BA, or/and MS. Preferred Qualifications: Prior experience in the pharmaceutical industry is preferred. Previous experience in leadership with people manager skills. Successful candidate will be extremely detail-oriented, have strong analytical skills, and the ability to consistently achieve high levels of accuracy within a dynamic environment. Team player, with the ability to work well with people at various levels local and global. Strong knowledge of Good Manufacturing Practices (GMPs). Excellent verbal, written, and interpersonal communication skills. Strong computer, organizational, and project management skills. Able to work independently. Demonstrates attention to detail and accuracy. Excellent organizational and communication skills are considered critical in executing the role successfully. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. #J-18808-Ljbffr
For Current Gilead Employees and Contractors: At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description QA Specialist II position in QA Supplier Systems Group, Gilead Sciences Ireland UC Cork Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. The Position This role is a QA Specialist II, permanent role in the GSIUC QA Department, under the QA Supplier systems group. This specific role is required for QA oversight for all GXP Suppliers and Service providers involving External audit Management, QAG Management, External Deviation ownership, approval and coordination, local supplier management involving qualification, approval, and monitoring. This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions. Essential Duties and Job Functions: Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements. Review and Approval of the Introduction of new Suppliers/Service providers and update in scope of approved Suppliers/Service providers i.e change control. Completion and approval of Qualification review records in the Supplier management system within Gilead QMS to support approval of new supplier/service provider introduction/new material introduction. Approval of new supplier and material part numbers within Gilead’s product lifecycle management system. Periodic Evaluation/Continuous monitoring of approved Suppliers/Service provider. Review of approval of Supplier appraisal reports. External Audit Management. Quality agreement Management. Approval of External Deviations associated with Suppliers/Service providers including full supplier investigations and tracking/trending supplier/material issues. Coordination of External Deviations associated with Cxo’s. Completion of yearly Excipient Supplier evaluation including completion of audit frequency assessment and GMP criticality gap assessment review. Assessment and Approval of Supplier/Service provider Notifications including changes and quality issues. External and Internal auditing. Support for regulatory and corporate audits. Participates in authoring, reviewing, and approving Standard Operating Procedures (SOPs)/other types of controlled documents. Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions. Review and approval of GMP Deviation investigations and CAPAs if required. Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP. Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings. Normally receives very little instruction on routine work, general instructions on new assignments. Knowledge, Experience and Skills: Prior experience in pharmaceutical industry is preferred (ideally within a QA role). Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems). Demonstrates working knowledge of quality assurance systems, methods, and procedures. Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations. Demonstrates audit and investigation skills, and report writing skills. Good verbal, written, and interpersonal communication skills. Proficiency in Microsoft Office applications. Typical Education & Experience: Relevant experience in a GMP environment related field and a BS or MS. Behaviours: Positive attitude and enjoys working as part of a team. Resilient profile with the ability to deliver in a challenging environment. Ability to engage and manage multiple stakeholders to achieve the objective. Curious with learning agility. Operationally excellent. Organised with systematic approach to prioritisation. Process orientated to achieve the business objective. Gilead Core Values: Integrity (always doing the right thing). Teamwork (collaborating in good faith). Excellence (working at a high level of commitment and capability). Accountability (taking personal responsibility). Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. #J-18808-Ljbffr
Senior Manager Supply Chain Apply locations Ireland - Cork time type Full time posted on Posted 17 Days Ago job requisition id R0043115 At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Senior Manager, Supply Chain The Senior Manager, Supply Chain will play a key role as part of the GSIUC Planning group within the Materials Management department. He/She will support the function in executing the Supply Planning processes for the portfolio worked through GSIUC Operations. This role will partner with Global Supply Chain in receiving the MPS hand off and working this through the cycle to translate to an achievable plan. The role will also support the development of processes across the function. The Senior Manager will partner with business owners within the wider Gilead Supply chain and operations teams to deliver on the MPS. The successful candidate will have detailed knowledge of supply chain management and ERP systems. The successful candidate will be required to work across organizational, cultural and geographic boundaries to optimize company strategic results. Responsibilities: Partner with Global Supply Chain planning to receive, analyze and provide feedback on the MPS and reach consensus on an achievable plan aligned with GSIUC operations that meets patient needs. Responsible for inventory reporting & performance for products assigned including the evaluation & remediation of low stock & potential obsolescence/expiry risks to support supply & financial planning. Responsible for the development of a viable plan (Master Production Schedule) in Kinaxis to support product supply & network visibility. Responsible for the escalation & remediation of supply risks to ensure uninterrupted patient supply for products. Responsible for the preparation of Product updates for & participation in Site, Regional & Global Sales & Operation forums. Responsible for the support of Budget & LE processes to improve inputs and outputs across the site functional areas based on one true set of demand & supply numbers. Partner with relevant functions to effectively incorporate new products, impacts of artwork changes and capacity impacts. Monitor, manage and report out on local and global KPIs relating to MPS, performance to plan and associated supply chain metrics. Utilize data and available technology to derive actionable insights to drive efficiencies and cost management. Contribute to long-term supply chain strategy with a focus on scalability and sustainability. Implement best practices and innovations in MPS and broader supply chain processes. Lead the preparation and communication of complex ‘current state’ and ‘future state’ documents. Support strategy, roadmap management & process mapping to support future state supply chain models and strategic decisions. Create business cases for identified process improvements and solutions. Use informal management skills to work with cross-functional groups and contractors to ensure successful and timely deliverables. Experience & Qualifications: Primary degree in Business, Science or Engineering discipline. Master’s degree and/or professional qualifications in supply chain management desired. Lean/Six Sigma certification and APICS CPIM and CSCP certifications preferred. Extensive experience in Supply Chain Management with a proven track record in MPS, production planning or related roles. Experience in project/portfolio management role. Experience in pharmaceutical operations/cGMP environment highly desirable. Deep supply chain knowledge with an ability to identify and analyze and summarize business problems in the end-to-end context and pull the key stakeholders together to form cross-functional responses. Proficiency in Supply Chain planning software (e.g. SAP, Kinaxis RR). Experience managing relationships with internal stakeholders and external business partners. Demonstrates a collaborative mindset, nurtures teamwork and influences cross-functionally. Excellent verbal and written communication including strong presentation and group speaking skills. Excellent organizational skills. Excellent project management skills. Excellent analytical skills – ability to manage large datasets. Must have a desire to learn new business operations and have a continuous improvement mindset. Gilead Core Values Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. #J-18808-Ljbffr
Senior Maintenance Engineer Location: Ireland - Cork Time Type: Full time Posted on: Yesterday Job Description The Position We are seeking a highly motivated individual for the role of Senior Maintenance Engineer . Reporting to the Associate Director of Engineering Operations & Compliance, as the Senior Maintenance Engineer, you are responsible for driving toward exceptional equipment performance to meet company goals. You will manage a team of maintenance technicians and contractors to support the strategic direction of the company’s maintenance program to ensure equipment reliability meets production operational demands. Responsibilities Include: Implement maintenance strategy aligned with the company's goals and objectives, establishing and maintaining a comprehensive maintenance program to ensure the reliability and availability of all equipment and facilities. Provide strong leadership to the maintenance teams, fostering a culture of excellence, collaboration, and continuous improvement. Set priorities for the team to ensure task completion as part of the overall department strategy, providing staff with coaching, training, and opportunities to develop skills, and giving ongoing constructive and timely feedback on performance. Manage maintenance infrastructure, monitor all systems status, and analyze to identify trends. Develop and manage preventative, corrective, and predictive maintenance programs to ensure cost-effective and reliable operation of all equipment and systems. Implement predictive and preventive maintenance practices to minimize downtime and optimize equipment performance. Monitor KPIs for equipment breakdowns, calibrations, and PM, and implement corrective and preventive actions. Ensure all maintenance activities comply with regulatory requirements, including FDA and GMP standards, and maintain accurate documentation/records to support regulatory audits and inspections. Manage the maintenance budgets, ensuring efficient resource allocation and identifying cost-saving opportunities to implement cost-effective solutions. Promote a culture of safety responsibility within the engineering and maintenance teams. Engage in Cross Functional Team activities to address and mitigate any root cause problems with preventative maintenance and machine performance. Develop Preventative Maintenance methods to minimize mean time between failure and maximize OEE. Collaborate across PDM Manufacturing sites to implement shared and harmonized processes. Knowledge, Experience and Skills: Degree qualified with extensive experience in Maintenance management. Experience in Pharmaceutical manufacturing and/or Biotechnology operations/GMP environment. Strong Technical Knowledge of Equipment reliability engineering. Demonstrates excellent verbal, written, and interpersonal communication skills. Ability to act on own initiative. Experience in the delivery and management of maintenance management systems. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit, select, and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis. #J-18808-Ljbffr
Senior Packaging Engineer Apply locations: Ireland - Cork time type: Full time posted on: Posted 30+ Days Ago job requisition id: R0042466 Job Description Senior Packaging Engineer I, Cork Description: The Senior Packaging Engineer position is an exciting opportunity to become part of the Global Manufacturing, Packaging & Labelling Business Operations (MPLBO) organisation at Gilead. The Senior Packaging Engineer is a highly visible role and shall be primarily responsible for the New drug product launches, tech transfers of Oral Solid Dose (OSD) and Combination devices/assembly/kitting, CMO Packaging operations, Packaging COGS reduction projects and GMP documentation to support the development and implementation of packaging solutions for a range of Gilead products across the Gilead Manufacturing network. The Senior Packaging Engineer shall also be responsible for designing and conducting package testing and transportation studies for a range of pack formats, i.e., bottle, combination products and glass vial products including cold chain technologies. The Packaging Engineer shall be required to provide ongoing technical and operational support to Contract Manufacturing Partners (CMOs) globally and to contribute to the development of the packaging capabilities. Job duties include: Packaging Engineering & Operations: Support and/or lead the planning and execution of packaging projects for a wide variety of project types including but not limited to New Product Introductions, Tech Transfers, Quality Workstreams like RCA/Deviation/CAPA management, Supplier Changes, Cost Savings Initiatives at multiple internal and external packaging sites. Support and/or lead external packaging operations for Contract packaging site(s) in the EMEA region. Prior CMO Management experience in EU is essential. GMP documentation and packaging systems expertise to efficiently manage change controls, packaging & labelling specifications, technical documentation/reports etc. With minimal guidance, determines the functions most critical to departmental success and supports priorities accordingly. Position requires technical knowledge of packaging materials, processes, qualification & validation requirements in high volume manufacturing set up. The Senior Packaging Engineer will work closely with multiple internal and external stakeholders including Quality, Validation, Regulatory, Labelling Operations, Supply Chain, CMO Management and Packaging Suppliers. An understanding of Packaging Lifecycle Management software/systems to manage documentation workflow is an advantage. Device and Kit Assembly Support and/or lead the engineering, operational and testing of secondary packaging presentations for combination devices/kits to achieve project deliverables. Accountable for developing innovative, creative, and cost-competitive secondary packaging/kitting solutions that meet the needs and requirements of our patients, environment friendly, and in line our quality standards. Understanding of major regulatory requirements, to support review of regulatory submission documents, plans, protocols, and reports etc. Influence understanding and interpretation of packaging regulations. Represent MPLBO as specialist on Device Projects, ensuring the voice of customer is captured during strategic discussion. Serialisation & Aggregation Position requires basic understanding of Serialization requirements such as EU FMD, DSCSA and other serialization/aggregation processes. Project Management The Senior Packaging Engineer shall support packaging projects and will be required to follow global guidelines on project delivery throughout the project lifecycle, project business cases, project charters, project scheduling, progress reporting. Use change control systems and project governance policies & systems. Collaborate with on-site and off-site stakeholders to support global initiatives and projects. Cost Efficiency and Continuous Improvement Lead and oversee approved cost savings projects across the sites and CMOs to meet the near- and long-term Cost efficiency targets. Analyze packaging engineering processes and documentation practices to identify and implement continuous improvement initiatives. Knowledge, Experience and Skills: Degree in Packaging/Device/Quality Engineering or related field essential. Extensive experience within the pharmaceutical, biotech or related industry. Strong technical and scientific skills with proven experience in the development of packaging solutions for OSD, parenteral and/or device packaging. Demonstrates strong knowledge of cGMP & regulatory processes. Experience of primary and secondary packaging processes, device and kitting assembly process, transportation studies, qualification/validation is essential. Project Management and Stakeholder management experience is essential. Strong communication, teamwork and organizational skills are essential. Demonstrates excellent verbal, written, and interpersonal communication skills. Behaviours Ability to engage and partner with multiple stakeholders to achieve the objective. Curious with learning agility. Operationally excellent. Organised with systematic approach to prioritisation. Process orientated to achieve the business objective. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. #J-18808-Ljbffr
Senior Director, Integrated Supply Planning At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description This position is responsible for developing and directing the overall strategy of the production planning, purchasing, material control, inventory control and shipping/receiving functions. Specific Job Responsibilities: May develop and implement Supply Chain strategy for multi-country regions. Coordinates the activities of department management, and provides direction and assistance on resolution of complex issues, compliance issues and potential problems related to production planning and material management. Makes or recommends appropriate decisions consistent with strategic direction. Ensures that personnel, equipment, material and services are provided as needed to maintain acceptable inventory levels. Implements and maintains material control systems, policies, processes and procedures, ensuring a controlled flow of approved materials timed to meet production requirements. Provides expertise and guidance in establishment and maintenance of the production control system. Serves as liaison between the company and the various governmental agencies. Directly interfaces with regulatory agencies as required. Coordinates interdepartmental activity with Quality Assurance, Manufacturing, Engineering and Contract Administration. Reviews, approves and/or implements changes to controlled documents as needed. Develops and approves new applications based on professional principles and theories, with a view to broader cross-functional implications. Aligns resources, prioritizes strategies, establishes targets, and implements cost-out initiatives with Global demands. Drives SOP process that is integrated with global processes and timelines. May establish standards, policies, and key vendor relationships/partnerships within the region of responsibility. Basic Requirements: Relevant experience in related field and a BS, BA; OR MA/MBA. Preferred Knowledge / Experience: Deep expertise in predictive analytics and data modeling. Working experience with SAP S/4 HANA. Able to develop complex concepts, techniques, and standards. Able to develop solutions to complex problems which require an in-depth degree of ingenuity, creativity and innovativeness. Challenges are frequently unique and solutions may serve as precedent for future decisions, which affect the entire organization. Recommends organizational objectives and interprets company policies. In-depth expertise in EU and international cGMPs. Able to interpret, execute, and recommend modifications to department policies. Demonstrates effective communication skills and the ability to deal across several multi-national agencies, sites and organizations. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. #J-18808-Ljbffr
Associate Director – Supply Chain Planning Global Process Lead Location: Ireland - Cork Time Type: Full time Posted on: Vor 3 Tagen Job Description Position: Associate Director – Supply Chain Planning Global Process Lead Overview: The Supply Chain Planning Global Process Lead (GPL) is responsible for driving innovation, efficiency, and maturity within the supply chain through the implementation of improved processes and practices. This role focuses on optimizing and standardizing supply planning, demand planning, site scheduling collaboration, and product segmentation across the PDM (Product Development and Manufacturing) organization. As part of the GSC Excellence & Strategy team, the GPL will play a pivotal role in providing leadership and direction, acting as an enabler across GSC and PDM value streams to clarify business processes and solutions. Key Responsibilities: Process Optimization: Partner with planning operations to identify opportunities for streamlining supply chain planning processes, including product segmentation and the integration of demand and supply planning to execution across the end-to-end supply chain. ERP Governance and Collaboration: Serve on the ERP governance council and assess proposed ERP system changes, collaborating with both business and IT to evaluate business needs and value propositions for system enhancements. Process Design and Assessment: Lead process design sessions, conduct process health assessments, and develop solutions in collaboration with Global Supply Chain, Direct Procurement, and Commercial Trade Operations. Utilize tools such as Kinaxis RapidResponse and IBP for network supply planning and demand signal analysis. Standardization and Best Practices: Advise on and implement standardized processes, procedures, and best practices to ensure consistency and compliance across all global supply chain operations. Performance Metrics: Establish and monitor key performance indicators (KPIs) to measure the effectiveness of supply chain processes. Cross-Functional Collaboration: Work closely with procurement, logistics, manufacturing, and quality assurance teams to align and ensure adherence to supply chain processes. Technology Integration and Innovation: Lead the assessment and integration of strategic technology platforms to optimize supply chain processes, identify emerging technologies, and partner with IT and system integrators to deliver process improvements. Process and System Integration: Ensure seamless integration of supply chain processes with other business functions, including finance and strategy. Support system/process implementation activities such as design, data migration, and training. Process Improvement Leadership: Take ownership of process governance projects, identify and address process gaps, develop and maintain process standards, and provide training and coaching to teams on process excellence. Qualifications: Communication and Leadership: Strong interpersonal, communication, and presentation skills with proven team management abilities. Must be able to engage and influence cross-functional stakeholders and foster a positive work environment. Problem-Solving and Innovation: Demonstrated ability to solve complex process and technology challenges, with a focus on delivering innovative solutions. Proven track record in driving process improvements and delivering measurable value. Analytical and Critical Thinking: Excellent analytical skills to evaluate data and develop actionable insights. Ability to think creatively and explore non-traditional solutions. Required Experience and Education: Extensive experience and a BS/BA degree, or Extensive experience with an MA/MBA. Experience in pharmaceutical operations or a cGMP environment is highly desirable. Experience in supply/demand planning operations and managing material transfers. Bachelor's degree in Supply Chain Management, Operations Management, Business Administration, or a related field (Master’s preferred). Certification in Supply Chain Management (e.g., APICS, CSCMP) is a plus. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. All employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis. #J-18808-Ljbffr
