QA Manager - Biologics
This is a 6‑month contract position based in Leiden, The Netherlands, requiring a minimum on‑site presence of 4 days per week. The Quality Assurance Manager will play a key role in ensuring compliance with EU GMP standards and supporting biologics production in an aseptic/sterile manufacturing environment. Fluency in Dutch (spoken and written) is essential to effectively collaborate with local teams and stakeholders. The role demands strong QA leadership, regulatory expertise, and hands‑on experience in sterile operations to safeguard product quality and operational excellence.
Key Responsibilities
- Lead QA oversight of aseptic biologics manufacturing, testing, and release activities.
- Ensure compliance with EU GMP and relevant regulatory frameworks.
- Review and approve batch records, deviations, CAPAs, and change controls.
- Drive continuous improvement initiatives across quality systems.
- Provide QA support during audits and inspections.
- Collaborate cross‑functionally with production, QC, and regulatory teams.
- Train and mentor staff on quality standards and procedures.
Requirements
- Proven experience in pharmaceutical/biotech QA management.
- Strong knowledge of EU GMP and regulatory expectations.
- Direct expertise in aseptic processing, sterile manufacturing, and biologics production.
- Fluent in Dutch (spoken and written).
- Ability to work on‑site in Leiden at least 4 days per week.
- Excellent communication and leadership skills.
- Detail‑oriented, proactive, and able to manage multiple priorities.
Contract Details
- Duration: 6 months
- Competitive daily rate
- Immediate start preferred
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