Head of Quality (UK/EU)

An opportunity has arisen for an experienced Head of Quality to lead and enhance the Quality function across multiple sites within a regulated GMP and GDP pharmaceutical manufacturing environment.

This strategic position is integral to ensuring compliance, operational excellence, and a strong quality culture within the organisation.

Role Overview

As a key member of the Senior Leadership Team (SLT), the Head of Quality will be responsible for leading Quality Assurance (QA) operations, overseeing Qualified Person (QP) oversight, and ensuring the harmonization of the Quality Management System (QMS) across multiple UK sites. The role will play a pivotal part in regulatory compliance, aseptic processing, supplier management, and continuous improvement initiatives.

This is a highly influential position, requiring strong strategic leadership, regulatory expertise, and the ability to drive a quality-first mindset throughout the organisation.

Key Responsibilities

• Quality & Compliance Leadership- Provide strategic direction for Quality Assurance, Quality Systems, and compliance activities across multiple manufacturing sites.
• GMP & GDP Oversight- Ensure full adherence to UK and European regulatory requirements, maintaining an audit-ready state at all times.
• Multisite Operations & Quality Systems- Lead the harmonisation and continuous improvement of QMS, ensuring consistency across all locations.
• QP Oversight- Ensure sufficient Qualified Person (QP) resources are available to support product release activities in line with regulatory requirements.
• Aseptic Processing & Sterility Assurance- Maintain high standards in aseptic manufacturing, driving process validation and risk-based decision-making.
• Regulatory & Audit Management- Lead regulatory inspections, internal audits, and supplier quality programs, ensuring all findings are addressed effectively.
• Continuous Improvement- Promote a culture of quality excellence, identifying opportunities for process optimisation and operational efficiencies.

Key Requirements

• Degree in a relevant scientific discipline (pharmacy, chemistry, biology, or equivalent).
• Expert experience in Quality Assurance leadership within a regulated pharmaceutical manufacturing environment.
• Comprehensive knowledge of UK/EU GMP and GDP regulations and experience hosting regulatory inspections.
• Proven experience managing Quality Systems and leading continuous improvement initiatives.
• Strong leadership skills, with the ability to develop and mentor high-performing teams.
• Experience in aseptic processing and sterility assurance is highly desirable.