Head of Manufacturing Operations
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.
Seniority level
Employment type
Job function
- Production and Management
- Industries: Pharmaceutical Manufacturing and Biotechnology Research
Note: This description focuses on the responsibilities and qualifications for the Head of Manufacturing Operations role at a UK-based pharmaceutical facility.
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