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Senior Director, External Manufacturing Quality, Cell Therapy
Bristol Myers Squibb. To define and shape the Quality strategy for global Contract Manufacturing Organizations (CMO) and associated Contract Test Labs (CTLs) management for the Cell Therapy External Manufacturing (ExM) network.
Posted 4/25/2026full-timeMadison • Massachusetts, New Jersey • 🇺🇸 United StatesSenior💰 $222,610 - $288,637 per yearWebsite
About the role
Key responsibilities & impact- To define and shape the Quality strategy for global Contract Manufacturing Organizations (CMO) and associated Contract Test Labs (CTLs) management for the Cell Therapy External Manufacturing (ExM) network.
- To ensure a high level of cGMP compliance and the safety, efficacy, and quality of externally manufactured commercial products.
- To lead a team of Quality Senior Directors or others in the oversight of the External Manufacturing Network.
- To recruit and develop global talent to sustain local and global competitiveness.
- To support audits and Health Authority inspection for the CMOs as necessary, including the assistance in the generation of HA responses and CAPAs.
Requirements
What you’ll need- Minimum bachelor’s degree in science or pharmaceutical related fields (Chem, Pham, Bio, Chem Eng).
- Advanced degree preferred.
- Mastery of global Quality compliance processes and regulations, e.g., cGMP/GDP regulations for External Manufacturing QA.
- A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.
- Thorough understanding of technical areas related to pharmaceutical and/or biological manufacturing, sterility assurance, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.
- >15 years of experience managing Quality and Compliance organizations.
Benefits
Comp & perks- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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Hard Skills & Tools
cGMP complianceGDP regulationsQuality compliance processesQuality controlQuality assuranceStatistical methodsPharmaceutical manufacturingBiological manufacturingMicrobiological analysesChemical analyses
Soft Skills
LeadershipTeam managementTalent developmentStrategic planningCommunication
Certifications
Bachelor's degree in scienceBachelor's degree in pharmaceutical fieldsAdvanced degree (preferred)