Related skills
regulatory filings gmp quality systems capa cgmp📋 Description
- Lead Quality Compliance group, incl. quality systems, inspection management, and training
- Ensure implementation and maintenance of the Quality System at Bridgewater for GMP compliance
- Direct cGMP programs and promote quality culture across functions (Quality, Manufacturing, MSAT, and more)
- Oversee Document Management System and Data Integrity with 21 CFR Part 11
- Lead site readiness for regulatory and customer inspections and audits
- Manage CAPA, change controls, quality events, investigations, and regulatory filings support
🎯 Requirements
- Bachelor’s degree or higher in a scientific or engineering discipline
- 10+ years in GMP pharma/biologics/cell/gene therapy with Quality Systems and Regulatory CMC
- 5+ years of leadership and knowledge of relevant cGMP regulations
- Excellent knowledge of regulations for biologics and cell/gene therapy products
- Strong GMP knowledge; experience with on-site regulatory inspections required
- Experience preparing regulatory submissions and health authority responses
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