Interim Head of Quality

Walker Cole International is supporting a UK-based life sciences organisation specialising in the manufacture of biological products in the appointment of an Interim Head of Quality. This role will provide strategic leadership and oversight of the Quality function, ensuring compliance with UK and international GxP requirements while supporting ongoing manufacturing and operational activities within a highly regulated environment.

This position will play a critical role in maintaining and enhancing the organisation’s Pharmaceutical Quality System (PQS), ensuring compliance with global regulatory standards, and acting as a key point of contact with regulatory authorities. The successful candidate will provide both strategic direction and hands-on leadership across quality systems, manufacturing quality, and cross-functional teams.

Key Responsibilities

• Provide leadership and oversight of the Pharmaceutical Quality System (PQS) to ensure continued compliance with GMP, GDP and applicable UK/EU regulatory requirements
• Act as the senior Quality leader and primary contact with regulatory authorities, including the MHRA
• Ensure the organisation maintains a constant state of inspection readiness
• Provide strategic and operational leadership across GMP manufacturing of biological/biopharmaceutical products
• Oversee and approve core quality processes including:
  • Deviations
  • CAPA
  • Change control
  • OOS/OOT investigations
  • Complaints and recalls
  • Document and record management
• Maintain oversight of batch certification/release, manufacturing, testing, storage and distribution activities
• Provide leadership and governance for Quality Risk Management and continuous improvement initiatives
• Oversee supplier qualification, third-party management and Quality Technical Agreements
• Collaborate closely with Manufacturing, QC, Regulatory Affairs, Supply Chain and Engineering to ensure compliant and efficient operations
• Support and mentor Quality teams, fostering a strong quality culture across the organisation
• Review and approve key quality documentation including SOPs, policies, validation documentation and quality reports
• Provide expert guidance on regulatory expectations for biological and sterile manufacturing environments

Required Experience and Skills

• Proven experience as Head of Quality / Senior Quality Leader within biopharmaceutical, biotechnology or advanced therapy manufacturing
• Strong working knowledge of UK GMP (EU GMP), GDP and wider GxP regulations
• Extensive experience managing and developing Pharmaceutical Quality Systems (PQS)
• Demonstrable experience hosting and leading MHRA and international regulatory inspections
• Strong expertise in quality processes including CAPA, deviations, change control, QRM and supplier management
• Experience overseeing GMP manufacturing and release of biological medicinal products
• Strong understanding of aseptic processing, sterile manufacture, or complex biologics (desirable)
• Ability to work collaboratively with senior cross-functional stakeholders
• Strong leadership, organisational and communication skills
• Comfortable operating in an interim, hands-on leadership role

Working Pattern

Hybrid (UK)

Contract Length

6 months

Rate

Day rate negotiable depending on experience

Location

United Kingdom

Keywords

Head of Quality | GMP | Biologics | Biopharmaceuticals | PQS | QMS | CAPA | MHRA | GMP Manufacturing | Contract | Regulatory Compliance