QA GMP Specialist

QA GMP Specialist

Start: ASAP / Q1 2026

End: 12‑month contract

Location: Sassenheim, Netherlands (Hybrid - 3 days onsite)

Hours: Full-time (40 hours per week)

Sector: Pharmaceutical / Biotech / GMP Compliance

About the Role

We are seeking a QA GMP Specialist to support a new viral vector manufacturing facility currently preparing for commercial readiness. In this role, you will ensure consistent GMP compliance across production processes, documentation, and quality systems. You will support change controls, lead deviations, perform risk assessments, and prepare the organization for internal and external audits.

The QA GMP Specialist operates within the Centre of Expertise (CoE), collaborating closely with Operations and New Product Introduction teams to translate technical processes into compliant, shop‑floor‑ready instructions and systems.

Key Responsibilities

• Review and update GMP documentation to ensure ongoing compliance with regulatory and internal standards.
• Write, manage, and facilitate change controls related to GMP production processes.
• Lead deviations and root cause investigations, ensuring timely follow‑up and closure of non‑conformance records.
• Participate in and/or facilitate Quality Risk Assessments (QRA).
• Coordinate and support internal and external audits in roles such as primary contact, SME, scribe, or back‑office lead.
• Coordinate internal batch release processes and ensure proper end‑to‑end documentation.

Who We're Looking For

• Bachelor's or Master's degree in a Science or Engineering discipline.
• 2-8 years of experience in biotechnology or biopharmaceutical GMP manufacturing.
• Strong understanding of cGMP and preferably Annex 1 requirements.
• Experience working with electronic quality systems (e.g., Comet, TruVault).
• Proficiency with MS Office tools, including Excel, Visio, SharePoint, Word, and PowerPoint.
• Excellent communication skills in English; Dutch is preferred.
• Strong stakeholder management and influencing skills within a complex matrix organization.

Preferred:

• Experience supporting audits or inspections in manufacturing environments.
• Familiarity with viral vector, biologics, or aseptic production environments.
• Ability to manage multiple priorities and devise effective solutions in a fast‑paced setting.

Let op: vacaturefraude

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Important: job fraud

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* If you're unsure whether a vacancy or contact person is legitimate, please reach out to us directly using the official contact details on our website.