Senior GMP QA Specialist - Biotech/Viral Vector (Hybrid)

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

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.