Director of Quality Assurance

My client is seeking an experienced Director of Quality Assurance to lead the site Quality function and champion a culture of compliance and continuous improvement across manufacturing and laboratory operations.

This is a senior leadership position with responsibility for the Pharmaceutical Quality System (PQS), regulatory inspection readiness, and the development of a capable, engaged quality team. The successful candidate will work closely with Operations, Technical, and Regulatory Affairs to uphold GMP standards while supporting the site’s growth plans.

Key Responsibilities

• Provide leadership across Quality Assurance and Quality Control at the site.
• Own and continuously improve the Pharmaceutical Quality System in line with EU GMP and MHRA expectations.
• Act as the site’s primary point of contact for regulatory, customer, and third-party audits.
• Manage CAPA, deviations, change control, product quality reviews, and risk management processes.
• Ensure validation activities (process, cleaning, analytical) meet regulatory and internal requirements.
• Maintain inspection-ready documentation, SOPs, and technical agreements.
• Track and report quality KPIs, driving data-led improvement projects.
• Manage the quality budget, resource planning, and succession pipeline.
• Coach and develop the QA and QC teams to build technical depth and accountability.

About You

• Degree in pharmacy, chemistry, biology, or a related scientific discipline.
• Substantial quality leadership experience within an MHRA- or EMA-regulated pharmaceutical manufacturing environment.
• Detailed working knowledge of EU GMP, ICH guidelines, validation, and risk management.
• Demonstrated success leading regulatory inspections and customer audits.
• Strong influencing, communication, and people development skills.
• Pragmatic, solutions-focused, and committed to continuous improvement.

What’s on Offer

• Senior leadership role with direct influence on site strategy and compliance.
• Opportunity to shape quality systems during a period of planned expansion.
• Competitive salary, bonus potential, and benefits package.
• Genuine scope for career progression within a growing organisation.

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