QA Specialist

Experienced Specialist QA – Advanced Therapies
Sector
Biopharmaceutical Manufacturing / Advanced Therapies / Quality Assurance
About the Site
The Leiden site supports the clinical and commercial manufacturing of Lentivirus used in CAR-T therapies. The facility operates in a highly regulated environment following Good Manufacturing Practices (GMP) and global quality standards to ensure safe and compliant production of advanced therapy products.

Role Summary
The Experienced Specialist QA acts as a quality expert providing oversight for Advanced Therapy manufacturing processes and products. The role ensures operations meet GMP and regulatory standards while supporting investigations, change controls, risk assessments, and quality oversight activities. The position collaborates closely with cross-functional teams including Operations, Warehouse, QC, GET, MSAT, and other Quality teams to ensure product quality and compliance.

Key Responsibilities
• Provide quality oversight during new product introduction, including GMP and PPQ runs.
• Support equipment qualification activities (IQ/OQ/PQ).
• Review investigations, support root cause analysis, and assess non-conformances.
• Ensure appropriate CAPAs are defined and implemented.
• Escalate critical quality or compliance issues when required.
• Participate in risk and hazard assessments.
• Review and approve GMP documentation and change controls.
• Perform aseptic processing quality oversight and support Quality-on-the-Floor initiatives.
• Support site or global projects as a QA SME.
• Participate in audits and inspections.
• Participate in an on-call rotation when quality oversight is required during manufacturing.

Required Qualifications (Non-Negotiable)
• Bachelor’s degree in a scientific discipline or related field.
• 4–6 years of experience in a GMP-regulated pharmaceutical environment (Manufacturing, QA, or QC).
• 2–4 years of experience in a Quality Assurance role.
• Strong knowledge of GMP and pharmaceutical quality systems.
• Fluent in English; Dutch is a plus.

Essential Experience & Skills
• Experience supporting manufacturing quality oversight in GMP environments.
• Knowledge of aseptic processing and sterile manufacturing requirements.
• Experience with deviations, investigations, CAPAs, and change controls.
• Strong analytical, problem-solving, and decision-making skills.
• Ability to collaborate with cross-functional teams and manage multiple priorities.

Practical Details
• Location: Leiden, Netherlands
• Work Model: On-site
• Duration: +12 months
• Start date: Asap