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Director of Quality Assurance
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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.
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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.
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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.
- Supportive, collaborative site culture in a desirable Cheshire location.
- Genuine scope for career progression within a growing organisation.
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