CLevelCrossing
Executive Director EXM Quality Biologics and Sterile
CLevelCrossing, New Brunswick, New Jersey, us, 08933
Executive Director EXM Quality Biologics and Sterile
Posted on Apr 17, 2020 Profile Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Responsibilities: Support Development of the Quality Strategy and the Quality Planning for the External Supply Organization. Ensure the Quality Assurance Agreements for Suppliers/CMOs are created and maintained according to Elanco requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved in the supply of the product. Manage/support the resolution of quality and technical problems within the Sterile EXM Suppliers in alignment with global standards. Deploy Quality Risk Management Techniques for quality oversight and problem resolution for CMOs to mitigate unacceptable risk in conjunction with BMS Manufacturing/Supply management and Quality. Support audits and Health Authority inspection for the CMOs as necessary, including the assistance in the generation of HA responses and CAPAs. Ensure that all critical and major issues, which may have an adverse effect on the quality of the product, or represent a risk of supply are escalated as per standard procedures to management and are resolved within stated timelines. Assure appropriate quality governance through performance of management reviews of quality KPI’s, metrics, process performance indicators and quality system signals and EXM CMO supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures. Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS. Provide oversight and resourcing where applicable within the EXMQ organization for projects (transfers, launches, due-diligence, other) – providing support where needed to ensure compliance with the QMS, and to facilitate issues escalation and resolution. Coordinate and/or provide SME input to BMS Policies, Directives, SOPs related to quality compliance when required. Lead communication and develop effective strategies & partnership with stakeholders from MSQ, OPEX, Supply Chain, Regulatory, Project Management, and Operations. Ensure all aspects of Quality Management of Sterile External Supplier/CMO is carried out according to the standards defined and is regularly reported and assessed for adequacy of performance. Build strong organizational capability for current and future needs. Recruit and develop global talent to sustain local and global competitiveness. Develop a high performance culture with the EXMQ organization. Support deployment of operational excellence strategies within EXMQ. Prepare and manage Sterile organizational Quality budget. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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Posted on Apr 17, 2020 Profile Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Responsibilities: Support Development of the Quality Strategy and the Quality Planning for the External Supply Organization. Ensure the Quality Assurance Agreements for Suppliers/CMOs are created and maintained according to Elanco requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved in the supply of the product. Manage/support the resolution of quality and technical problems within the Sterile EXM Suppliers in alignment with global standards. Deploy Quality Risk Management Techniques for quality oversight and problem resolution for CMOs to mitigate unacceptable risk in conjunction with BMS Manufacturing/Supply management and Quality. Support audits and Health Authority inspection for the CMOs as necessary, including the assistance in the generation of HA responses and CAPAs. Ensure that all critical and major issues, which may have an adverse effect on the quality of the product, or represent a risk of supply are escalated as per standard procedures to management and are resolved within stated timelines. Assure appropriate quality governance through performance of management reviews of quality KPI’s, metrics, process performance indicators and quality system signals and EXM CMO supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures. Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS. Provide oversight and resourcing where applicable within the EXMQ organization for projects (transfers, launches, due-diligence, other) – providing support where needed to ensure compliance with the QMS, and to facilitate issues escalation and resolution. Coordinate and/or provide SME input to BMS Policies, Directives, SOPs related to quality compliance when required. Lead communication and develop effective strategies & partnership with stakeholders from MSQ, OPEX, Supply Chain, Regulatory, Project Management, and Operations. Ensure all aspects of Quality Management of Sterile External Supplier/CMO is carried out according to the standards defined and is regularly reported and assessed for adequacy of performance. Build strong organizational capability for current and future needs. Recruit and develop global talent to sustain local and global competitiveness. Develop a high performance culture with the EXMQ organization. Support deployment of operational excellence strategies within EXMQ. Prepare and manage Sterile organizational Quality budget. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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