QA Specialist II (GMP/GLP)

Location: Netherlands, Hoofddorp

Company

Biopharmaceutical organization developing CAR T-cell and T-cell receptor engineered therapies for cancer immunotherapy.

What you will do

• Perform QA activities supporting regulatory compliance and internal quality procedures.
• Maintain quality programs and processes aligned with current GMPs and GLPs.
• Provide front-line QA support, including shopfloor rounds and real-time escalation support.
• Review and approve deviations and CAPA, and coordinate product-related investigations.
• Identify process deviations, contribute to SOP development, and support inspections and audits.
• Coordinate quality projects and participate in cross-functional teams working on complex assignments.

Requirements

• Bachelor’s degree with 3+ years of relevant experience, or Master’s degree with 1+ years of relevant experience.
• Strong working knowledge of GMPs and/or GLPs.
• Experience with deviation and CAPA management, impact assessments, and root cause investigations.
• Strong technical writing, reporting, documentation review, communication, and stakeholder-management skills.
• Proficiency in Microsoft Office applications.
• Experience in the pharmaceutical or biopharmaceutical industry is preferred.

Culture & Benefits

• Work focused on developing cancer therapies and personalized cell treatments.
• Cross-functional collaboration across quality, operations, and scientific teams.
• Opportunity to mentor junior staff and contribute to an inclusive, development-oriented workplace.
• Full-time employment in Hoofddorp, Netherlands.