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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Director of Quality Assurance employer: Executive Recruit
As a leading player in the multi-site operations sector, our company offers an exceptional work environment that fosters strategic thinking and innovation. With a strong focus on employee development, we provide ample opportunities for growth and advancement, alongside a collaborative culture that values each team member's contributions. Located across Scotland, Cumbria, and Yorkshire, we pride ourselves on our commitment to excellence and resilience, making us an attractive employer for those seeking meaningful and rewarding careers.