Contract QP - IMPs

Walker Cole International is supporting a Netherlands-based life sciences organisation specialising in the manufacture of Advanced Therapy Medicinal Products (ATMPs) in the appointment of a Qualified Person (QP). This role will provide oversight of batch certification and ensure full compliance with EU GMP requirements while supporting ongoing manufacturing and operational activities within a highly regulated advanced therapies environment.

This position will play a critical role in maintaining and strengthening the organisation’s Pharmaceutical Quality System (PQS), ensuring compliance with European and global regulatory standards, and acting as a key quality representative for regulatory authorities. The successful candidate will provide hands-on QP support across ATMP manufacturing, quality systems, and cross-functional teams.

Key Responsibilities

• Act as a Qualified Person (QP) named on the Manufacturing Authorisation, certifying batches in accordance with EU GMP and Directive 2001/83/EC

• Ensure all products are manufactured, tested, and released in compliance with EU GMP and applicable global regulatory requirements

• Maintain oversight of ATMP manufacturing operations, including cell and gene therapy products

• Ensure the organisation maintains a continuous state of inspection readiness

• Act as a key quality representative during regulatory inspections (e.g. Dutch Health and Youth Care Inspectorate (IGJ), EMA, and international authorities)

• Review and certify batch documentation, deviations, investigations, and change controls prior to release

• Provide QP oversight of:

  • Deviations and investigations

  • CAPA

  • Change control

  • OOS/OOT investigations

  • Complaints and recalls

  • Document and record management

• Provide expert guidance on ATMP manufacturing, aseptic processing, and contamination control strategies

• Support the ongoing development and continuous improvement of the Pharmaceutical Quality System (PQS)

• Collaborate with Manufacturing, QC, QA, Regulatory Affairs, and Supply Chain functions to ensure compliant and efficient operations

• Support supplier qualification, third-party oversight, and Quality Technical Agreements where required

• Promote a strong quality culture across the organisation

Required Experience and Skills

• Eligible to act as a Qualified Person (QP) under EU GMP requirements

• Proven experience certifying batches within ATMP, cell therapy, gene therapy, biologics, or sterile pharmaceutical manufacturing environments

• Strong working knowledge of EU GMP and wider GxP regulations

• Experience working with regulatory authorities, including IGJ, EMA, and/or other international agencies

• Demonstrable experience in batch certification and release of ATMPs or complex biological products

• Strong expertise in quality processes including deviations, CAPA, change control, and Quality Risk Management (QRM)

• Experience supporting and hosting regulatory inspections

• Strong understanding of EU GMP Annex 1 and ATMP regulatory requirements

• Excellent stakeholder engagement and communication skills

• Able to operate effectively in an on-site, hands-on contract role

Qualified Person | QP | ATMP | Cell Therapy | Gene Therapy | EU GMP | Annex 1 | Batch Release | Biologics | Pharmaceutical | Contract | Regulatory Compliance | Netherlands