Senior QA Specialist

Progressive; Leiden; Hybrid; EUR 65,000 - 85,000; Full time

Job summary

A leading biotechnology firm in the Netherlands seeks an experienced Senior QA Specialist to support a new viral-vector manufacturing facility. The role requires 8+ years of GMP experience in biotech or pharmaceutical manufacturing, focusing on deviation management, RCA, and ensuring audit readiness. Candidates should excel in a fast-paced environment with strong communication and stakeholder management skills. This is a full-time hybrid position with 3 days onsite per week, offering a significant opportunity to impact quality processes.

Qualifications

• 8+ years of GMP experience in biotech or pharmaceutical manufacturing.
• Hands-on experience with deviations, investigations, RCA, CAPA, and change controls.
• Strong understanding of cGMP requirements.

Responsibilities

• Review and maintain GMP documentation for compliance.
• Lead deviation, RCA, CAPA activities, and change controls.
• Ensure audit readiness and support Quality Risk Assessments.

Skills

GMP experience

Deviation management

Root-cause analysis

Change control management

Communication skills

Stakeholder management

Job description

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

Hours: Full-time (40 hours per week)

Sector: Pharmaceutical / Biotech / GMP Compliance

About the Role

We are looking for an experienced Senior QA Specialist (GMP) to support the new viral‑vector manufacturing facility in Sassenheim. As the site moves toward commercial readiness, the team needs someone who can step in quickly, operate independently, and take clear ownership of their responsibilities in a dynamic and fast‑paced environment.

You will play a key role within the Quality organization, working closely with Operations and the Centre of Expertise (CoE) to ensure processes, documentation and systems meet the highest compliance standards and are fully audit‑ready.

Key Responsibilities

• Review, update, and maintain GMP documentation to ensure regulatory and internal compliance
• Lead deviations, root‑cause analyses (RCA), CAPA activities, and change controls
• Support and/or facilitate Quality Risk Assessments
• Contribute to audit readiness, including acting as SME where required
• Collaborate with Operations and the CoE to translate technical processes into compliant, shop‑floor‑ready workflows
• Proactively identify improvement opportunities and independently initiate and follow up on actions

Who We're Looking For

We are seeking a senior professional who is not only technically strong but also able to present themselves confidently and navigate a complex, high‑tempo environment.

Must‑haves

• 8+ years of GMP experience in biotech or pharmaceutical manufacturing
• Demonstrated hands‑on experience with deviations, investigations, RCA, CAPA & change controls
• Strong understanding of cGMP requirements (Annex 1 experience is a significant advantage)
• Excellent communication skills and the ability to present yourself with confidence and clarity
• A proactive, self‑driven approach with the ability to take ownership in a busy environment
• Strong stakeholder management skills and the ability to prioritize effectively

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.