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GMP Quality Manager
- In close collaboration with the manufacturing teams:
o review of deviation investigations and related corrective and preventive actions of review of change controls
o review batch record documentation and support release of IMP for clinical studies
o review of annual product reviews
- Review quality agreements with external parties.
- Support the Global External Audit Program through the execution of qualification audits and routine GMP audits; Support HA inspection, mock inspections and pre-approval inspections and work with internal stakeholders and external parties to prepare for these inspections.
- Support follow-up of the above audits and inspections and ensure appropriate and timely CAPA implementation.
- Support internal audit program.
- Support the further build-out of quality processes and systems enabling successful launch of a commercial product.
Skills and personality
- 5y+ experience in a quality assurance role, dealing with biopharmaceuticals with experience in biological manufacturing operations.
- Experience with audits and experience with preparation of regulatory inspections (FDA, EMA, PMDA, ...) is a plus.
- In-depth knowledge of FDA and EU regulations and ICH Guidelines.
- Strong technical mastery, analytical and investigation skills.
- Able to work effectively together with both internal and external stakeholders.
- Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines.
- Fluent in English – our working language.
minimum 5 years
Submit your CV
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