Job Description

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
The Head of Manufacturing Operations will:

• 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.

Skills Required