Quality Assurance Specialist

QA Specialist

Sassenheim, Netherlands – Full-time, 1-year contract (possibility of extension)

Company Description

This leading biopharmaceutical company specializes in the development and manufacturing of advanced therapy medicinal products (ATMPs), with a strong focus on innovation, regulatory excellence, and patient impact. The Sassenheim site supports both clinical and commercial production of drug substances and starting materials for cell and gene therapy applications.

Job Description

As QA Specialist – Advanced Therapies , you will act as the primary QA representative for all quality-related activities across the production facility and QC laboratories. You will ensure compliance with GMP, cGDP, and regulatory expectations while serving as a key point of contact for internal stakeholders and external partners.

You will provide independent QA oversight for manufacturing operations, technology transfers, equipment qualifications, validations, and investigations, ensuring pragmatic, quality-driven decision-making in a dynamic environment. Working closely with cross-functional teams (Operations, QC, MSAT, MAM, Warehouse), you will help maintain and strengthen the site’s quality culture and inspection readiness.

Key Responsibilities :

• Provide QA oversight to manufacturing and quality control operations for advanced therapies at the site
• Supports setting the GMP standards and / or provides Quality guidance for :
• all GMP processes, e.g., Change Control, Doc Control, GMP Training, inspection readiness
• Facility, utility, and equipment design
• Technology and / or Analytical Transfer
• Qualifications and Validations
• Aseptic Processing and Annex 1 adherence
• Support GMP compliance across processes such as change control, document control, deviation / CAPA management, GMP training, and inspection readiness
• Review and assess quality investigations, root cause analyses, and product dispositions
• Guide and approve CAPAs and non-conformance management
• Lead or participate in risk assessments, internal audits, and global QA projects
• Oversee GMP training and contribute to a culture of continuous improvement and compliance through initiatives like GEMBA walks
• Represent QA in facility design and qualification projects (e.g., new Pollux facility)
• Serve as QA SME during audits and inspections (e.g., FDA, EMA)
• Review and approve documentation including protocols, reports, and change controls
• Participate in 24 / 7 QA on-call rotation for urgent quality issues

Essential Requirements :

Desirable Experience :

Additional Insights :

Interested?

Send your CV to Khanyi Mabena at k.mabena@panda-int.com or reach out directly at