QP

Walker Cole International is supporting a UK-based life sciences organisation preparing for the manufacturing and release operations within a regulated GMP environment. As part of this programme, we are recruiting a Qualified Person (QP) Contractor to provide expert certification and compliance oversight for biological products.

This role will support the business in maintaining MIA compliance, strengthening quality systems, and preparing for future manufacturing and commercial activities. The successful candidate will play a key role in ensuring ongoing regulatory readiness and robust batch certification processes.

Key responsibilities:

• Act as the named Qualified Person, providing certification and release of biological products in line with EU/UK GMP and regulatory requirements.

• Maintain oversight of the MIA licence and ensure continued compliance with MHRA expectations.

• Support readiness activities for the restart of manufacturing operations.

• Review and approve batch documentation, deviations, change controls, and CAPAs.

• Provide expert guidance on GMP compliance, quality systems, and regulatory standards.

Required experience and skills:

• Eligible to act as a UK/EU Qualified Person under permanent provisions.

• Proven experience in biological drug products within a GMP-regulated environment.

• Demonstrable experience in batch certification and regulatory compliance.

• ATMP experience is highly desirable.

• Strong knowledge of UK/EU GMP, MHRA requirements, and MIA governance.

• Ability to work autonomously in a contract role with minimal supervision.

• Strong documentation, communication, and stakeholder management skills.

• Experience supporting inspection readiness and regulatory audits.

Contract information:

Email: fk@walkercole.com 

Telephone Number: 0 208 103 5472

Working pattern:
Part-time contract, approximately 1 day per week (on-site)

Contract length:
Initial 6–12 month engagement (with potential extension)

Rate:
Competitive day rate, dependent on experience

Location:
Greater London

Keywords:
Qualified Person | QP | Biologics | ATMP | GMP | MIA | MHRA | Batch Release | Regulatory Compliance | Quality Assurance | Biotech | Life Sciences | Contract | Contractor

ID:
92682