Head Of Quality

Head of Quality
Reports To: General Manager
Direct Reports: QA Supervisor + team, QC Supervisor + team
Role Summary
This is a senior leadership position within a fast-moving pharmaceutical manufacturing/repackaging environment, responsible for overseeing all aspects of Quality Assurance (QA), Quality Control (QC), and regulatory compliance. You will set the strategy, ensure inspection readiness, maintain licences, and deliver continuous improvement across quality systems and operations.
The role is critical in ensuring compliance with GMP/GDP standards, supporting upcoming projects such as implementing an electronic QMS, and driving a culture of collaboration and high performance within the Quality function.
Key Responsibilities
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Leadership & Compliance
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Act as the primary contact for all Quality matters.
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Maintain and oversee compliance with MHRA and other regulatory standards.
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Ensure effective preparation for inspections and audits.
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Quality Systems & Risk Management
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Lead and maintain the QMS, implementing improvements and supporting transformation projects.
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Oversee investigation, CAPA management, deviations, and risk-based decision-making.
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Operational Excellence
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Support change-control processes and ensure timely resolution of quality issues.
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Oversee approval and maintenance of SOPs and GMP-related documentation.
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Always ensure inspection readiness for MHRA and customer audits.
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Team Development
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Manage QA and QC teams (approx. 16).
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Build a nurturing and developmental leadership style, coaching and motivating team members.
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Continuous Improvement
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Drive process improvements in the Quality function.
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Play a key leadership role in electronic QMS implementation and other site projects (office move, layout reconfiguration).
Candidate Requirements
Essential:
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Strong leadership and people management experience within GMP/GDP-regulated manufacturing or repackaging (not purely lab-based).
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Proven track record with MHRA inspections, including hosting audits and maintaining licences.
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Extensive experience in Quality Management Systems and change/implementation projects.
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Excellent knowledge of EU GMP and pharmaceutical regulations.
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Strong interpersonal skills with a collaborative, coaching management style.
Desirable:
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Experience of electronic QMS implementation.
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Additional auditor certifications.
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Broader operational exposure beyond Quality.
Key Attributes
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Excellent communication & stakeholder management.
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Decision-making and problem-solving under pressure.
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Organized, proactive, and continuous improvement mindset