The Role
Bristol Myers Squibb is looking to recruit a Senior Manager, Quality Compliance, External Manufacturing on a 12‑month fixed term contract.
Position Summary
The Senior Manager, Quality Compliance provides quality compliance oversight for pharma (intermediates, API and drug product/finished goods), and biologics CMOs within External Manufacturing. The position also drives effective implementation and continuous improvement of Quality Systems' compliance across the Global External Manufacturing network. In addition, the role provides comprehensive quality and compliance support to Quality operations, Alliance Partners, Third‑Party Customers/Contractors (TPCs/TPMs), and Marketing Authorization Holders (MAHs) to ensure BMS Good Manufacturing Practices (GMP) and regulatory standards are consistently met. The Senior Manager is also responsible for effective implementation of Quality Systems across Global External Manufacturing.
Duties / Responsibilities
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.
Serve as Lead Site Change Champion with responsibility for manufacturing launches and high‑complexity CMO technical transfer projects.
Lead the BMS Fact Finding Information Team (FIT) and Fact‑Finding Information Review Meeting (FIRM) processes for major investigations involving ExM manufacture.
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.
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.
Leadership & Process Ownership
Where applicable, lead and develop direct reports; build a high‑performance team culture and strong cross‑functional relationships.
Own all elements of the process including relevant procedures/forms, training materials, SharePoint content, and metrics where applicable.
Be primary subject‑matter expert for review of regulatory or directive changes.
Regularly review the process for effectiveness and elevate compliance risks to senior management.
Serve as the subject‑matter expert in audits / inspections.
Develop and implement proactive continuous improvement plans for the process.
Support Annual Product Reviews/APQRs, vendor approvals, bona fides, and stability protocol updates, where applicable.
Qualifications, Knowledge and Skills Required
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 25%, depending on business need.
Remote Work Flexibility
Based on your function, department or individual position, you may discuss with your Manager the option to work remotely up to 50% of the time, over a two‑week period, with the flexibility to choose the days that align with your collaboration needs.
Equal Employment Opportunity Statement
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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