Associate Director Quality Operations
vor 2 Wochen
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.Job Summary
Working in a cross-functional virtual plant team this position provides quality oversight of Contract Manufacturing Organizations (CMOs) through effective collaboration with the other VPT functions.
Primary responsibility is to support management of CMO disposition documentation, assure CMO compliance with BMS and applicable cGMP and international regulatory standards for biologics drug substance and drug product manufacture, testing, and distribution.
Responsibilities:
- In collaboration with Responsible Person and Qualified Person perform and oversight product disposition activities to ensure the timely supply of drug substance, drug product, and finished biological products
- Serve as a quality lead for the technical CMO projects related to commercial BMS product
- Own or provide quality evaluation and approval of the change controls related to commercial biological products from CMOs
- Provide quality decision on the deviations reported by CMOs for manufactured BMS products. Lead deviation meetings with CMOs.
- Prepare and review of Quality Agreements with external and internal manufacturing and testing partners
- Manage and report quality metrics in relation to CMO performance
- Review and collaborate with CMO and BMS sites on Annual Product Quality Reviews as required for endtoend product monitoring
- Work with CMOs to ensure commercialization and PAI readiness for biological products introduced to CMOs
- Review and approve analytical documentation in collaboration with the analytical SME
- Provide quality operational support during selfinspections, internal audits, and regulatory agency inspections at contract manufacturers and BMS.
- Support supplier relationship manager, global procurement, supply chain and manufacturing science and technology teams for the projects, technical transfers programs, supplier selection programs, and commercial manufacturing activities
- Review validation documents, deviations, and change controls and escalate any potential compliance gaps
- Escalate issues to senior management to ensure that issues are resolved to support BMS business and compliance requirements in a timely manner
- Evaluate external quality complaint investigations provided by CMOs
Required Competencies:
- Ability to assess the right balance between the business implications, technical considerations and quality decisions
- Ability to set up and implement quality expectations for technical projects based on regulatory and industry standards
- Ability to serve as a quality lead for technical projects
- Strong negotiation, communication and presentation skills across all levels both internal and external to BMS
- Demonstrated technical expertise in resolution of deviations, complaints, development of effective corrective and preventive actins (CAPA) and use of risk assessments
- Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met
- Excellent verbal, written and presentation skills in English
- Proficiency with the use of global systems (e.g. SAP, Microsoft Office).
- Strong strategic and analytical thinking, problem solving and rapid decision making skills
- Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment
- Confidence in negotiating and influencing without authority
- Proficiency in technical writing
- Minimum B.S. degree in relevant scientific discipline e.g., Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
- Minimum of 10 years' experience in aseptic or sterile manufacturing operations at the manufacturing site (manufacturing department, quality assurance and release, or manufacturing science/technology)
- At least 6 years in Quality Assurance, ideally in project management or product release
- Experience in biological product manufacturing
- Experience in contract manufacturing
- Good verbal, written and presentation skills in English
- Experience with complex technical writing, ideally with authoring investigations, quality risk assessments, process descriptions, or study protocols
Additional desired qualifications/experiences**:
- Ability to negotiate an
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