Provide quality compliance oversight for pharma (intermediates, API and drug product/finished goods), and biologics CMOs within External Manufacturing.
Drive effective implementation and continuous improvement of Quality Systems’ compliance across the Global External Manufacturing network.
Provide 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.
Lead continuous improvement and 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).
Write and/or review Standard Operating Procedures (SOPs) and other controlled documents to ensure compliance with BMS standards and cGMP requirements.

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 project management capability.

Senior Manager, Quality Compliance, External Manufacturing

Key skills