Regulatory Affairs Manager specializing in food industry compliance across US/North America. Leading regulatory strategies and communication for food ingredients and products.
About the role
- Senior Manager overseeing quality compliance and implementation of Quality Systems in external manufacturing. Supporting compliance with regulatory standards across Global External Manufacturing network at Bristol Myers Squibb.
Responsibilities
- 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.
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.
Benefits
- Competitive benefits, services and programs
- Balance and flexibility in work environment
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