Overview
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
* 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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