Senior Manager, QA Commercial Drug Substance & Intermediates
Genmab
Senior Manager responsible for GMP quality oversight of commercial Drug Substance and Biological Intermediates manufactured at external CMOs. This role provides expert QA guidance across supply chains, manages quality issues, and maintains pharmaceutical quality systems in alignment with regulatory requirements.
Responsibilities
- Lead QA representation for Drug Substance and Biological Intermediates in cross-functional project groups and external collaborations
- Provide expert guidance on GMP compliance and support resolution of complex quality issues
- Develop, maintain, and improve pharmaceutical quality systems aligned with GMP and GDP requirements
- Handle deviations, CAPAs, change controls, and perform batch review and release activities
- Support regulatory inspections, audits, and complaint/recall investigations as delegated QP
Requirements
- Expert knowledge of GMP legislation and guidelines for biologics Drug Substance and Biological Intermediates
- Experience with pharmaceutical quality systems, deviations, CAPAs, and change control processes
- Demonstrated expertise in quality risk management and batch review/release activities
- Strong cross-functional collaboration skills with CMOs, regulatory affairs, and internal stakeholders
- Experience with regulatory inspections, audits, and complaint/recall investigations
- Knowledge of Continued Process Verification and Quality Management Review processes
Ledig stilling opslået Indrykket for 12 dage siden
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