GMP QA Manager (maternity cover)
563040 DKK - 844560 DKK om åretGenmab
Fixed-term GMP QA Manager position covering maternity leave until July 2027, based in Copenhagen. Responsible for quality oversight of commercial drug products and finished goods, managing deviations, vendor compliance, and regulatory documentation within an integrated biotech company.
Responsibilities
- Review and release commercial drug products and finished goods as delegated qualified person
- Manage deviations, CAPAs, and change controls per regulatory requirements and company procedures
- Oversee quality assurance of contractors and vendors for outsourced GMP activities
- Support quality management reviews and annual product reviews
- Author and review quality management system documentation and procedures
Requirements
- Bachelor's or Master's degree in life science discipline
- Minimum 5 years pharmaceutical industry experience, preferably QA GMP
- Experience with drug product and finished goods GMP production and delegated QP responsibilities
- Fluent in English with excellent communication and collaboration skills
- Ability to work effectively in fast-paced, changing environments
Compensation: DKK 563,040–844,560 annual base salary
Ledig stilling opslået Indrykket for 2 dage siden
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