We are seeking an experienced leader to oversee day-to-day operations at a UK-based pharmaceutical manufacturing facility specialising in the production of unlicensed medicines (“specials”). The role requires a balance of strategic leadership and hands-on operational oversight to ensure regulatory compliance, efficiency, and the delivery of high-quality products that put patient safety first.Key Responsibilities

Ensure compliance and governance by maintaining SOPs, embedding GMP standards and data integrity practices, and sustaining a trained, competent workforce.Oversee production planning by translating forecasts and patient-specific orders into achievable schedules, while managing material flow, segregation, and availability.Manage batch execution and documentation to ensure the use of approved records, accurate reconciliation, and timely resolution of queries.Maintain facilities and equipment in partnership with Engineering, ensuring calibration, qualification, and effective contamination control measures are in place.Lead validation and change initiatives, supporting process validation, technology transfers, and process improvements under change control.Drive investigations and improvements by leading root cause analysis, implementing effective CAPAs, and reducing inefficiencies through Lean/Six Sigma methodologies.Foster people and culture development by building a high-performing team, setting objectives, coaching staff, and promoting a safety- and quality-first mindset.Act as subject matter expert during audits, ensuring the site remains in a constant state of inspection readiness.Support GDP and controlled drug management where applicable, ensuring full compliance with licence conditions in collaboration with the Responsible Person.Work closely with Quality leadership to jointly oversee compliance, approve controlled documentation, manage supplier performance, review batch records, and maintain readiness for internal and external audits.Experience and Qualifications

Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, Engineering, or a related scientific discipline.Extensive experience (7+ years) in GMP-regulated pharmaceutical manufacturing, with a strong track record in operational leadership (3-5 years).Proven success in achieving production targets while delivering improvements in yield, right-first-time metrics, and deviation rates.Demonstrated expertise in investigations, CAPA, change control, and working with cross-functional teams.Previous exposure to small-batch or patient-specific manufacturing is highly desirable.Personal Profile

We are looking for a leader who is:Decisive and calm under pressure, with the judgement to prioritise patient safety and compliance above all else.Highly detail-oriented, with deep knowledge of GMP and production controls.Skilled in planning, resource management, and operational delivery.Analytical, data-driven, and confident applying structured problem-solving tools.A clear and persuasive communicator, able to connect with both shopfloor teams and senior stakeholders.A role model for integrity, GMP behaviours, and a culture of continuous improvement.

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