Senior Manager, Quality Compliance, External Manufacturing

• Lead Continuous Improvement and/or Compliance projects supporting the External Manufacturing (ExM) or network.
• Serve as Local Process Owner with responsibility for assigned Quality Systems (e.g., Change Control, Deviations, CAPA, Complaints), ensuring procedures, training, metrics, and compliance are maintained.
• Lead the BMS Fact Finding Information Team (FIT) and Fact-Finding Information Review Meeting (FIRM) processes for major investigations involving ExM manufacture. Prepare and present the information to senior management in support of the FIT / FIRM processes.
• Support the Product Action Committee (PAC) process for all recalls associated with CMOs managed by ExM Support issuance of HA notifications (e.g. Field Alert Reports) where required.
• Provide quality/compliance support to the Quality Operations Managers. • Raise Notifications to Management (NTMs) for major and critical investigations where required.
• Review and approve responses to Health Authority (HA) observations prepared by CMOs to ensure regulatory alignment.
• Write and/or review Standard Operating Procedures (SOPs) and other controlled documents to ensure compliance with BMS standards and cGMP requirements.
• Represent ExM on global quality teams, initiatives, and cross-functional projects, providing quality/compliance subject matter expertise.

• Where applicable, lead and develop direct reports; build a high-performance team culture and strong cross-functional relationships. • Manage gaol setting, performance, and development of team members where applicable.
• Own all elements of the process including relevant procedures/ forms, training materials, share point content, metrics where applicable
• Display technical knowledge of the process and understand risks/weaknesses in the system
• Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with BMS policies/directives where applicable
• Responsible for ensuring the elements of the process are current and reflect current practices
• Be primary subject matter expert for review of regulatory or directive changes, responsible for coordination of input from key stakeholders into the impact assessment to the process
• Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, waste elimination) for their effectiveness and provide feedback to the Quality management team for action and remediation
• Own relevant process issues - speak to trends/issues/exceptions at ExM Quality Councils
• Own Health Authority commitments related to the process
• Serve as the subject matter expert in audits / inspections
• Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance
• Review process performance, lead remediation where needed, and escalate compliance risks to senior management.
• Support Annual Product Reviews/APQRs, vendor approvals, bona fides, and stability protocol updates, where applicable.

• BSc or equivalent in a scientific discipline such as Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy.
• 8-10+ years' experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory Affairs, or within a Health Authority agency.
• Extensive technical knowledge of chemical, biological, and/or pharmaceutical operations with firsthand experience in manufacturing, quality control, quality assurance, regulatory sciences, and R&D interfaces.
• In‑depth knowledge of cGMP and GDP regulations for the USA, EU, and other international markets.
• Direct experience interacting with Health Authorities (e.g., FDA, EMA) and supporting or leading inspections.
• Direct experience working with external manufacturers and providing quality oversight at CMO sites.
• Strong analytical and problem‑solving skills.
• Strong negotiation, communication, presentation, and interpersonal skills.
• Ability to build relationships and influence or enforce quality decisions at internal and external sites.
• Strong project management capability.
• Ability to balance business requirements with scientific and quality decision‑making.
• Highly detail‑oriented with strong organizational and follow‑up skills.
• Ability to work independently with minimal supervision.
• Comfortable working in a fast‑paced environment with dynamic timelines.
• Ability to lead, coach, and motivate team members across geographically dispersed locations.
• Strong collaboration and facilitation skills across multiple functional groups.
• Self‑motivated with the ability to manage and prioritize multiple projects simultaneously.
• Ability to achieve targets and adapt to changing business priorities.
• Strong presentation skills and confidence in public speaking.
• Travel requirement: typically approx. 10% but up to

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.