We’re supporting a leading pharmaceutical manufacturing organisation with a network of UK sites delivering critical diagnostic products. With continued growth, operational complexity, and regulatory expectations, we are seeking an experienced Site Manager to take full operational ownership of a key facility.
Reporting to the Head of Operations, with a functional relationship to Quality leadership, this is a highly visible role responsible for ensuring the safe, compliant, and efficient manufacture and distribution of pharmaceutical products.
This role combines hands-on operational leadership with strategic oversight, and would suit an experienced manufacturing or pharmaceutical professional with strong GMP knowledge and a track record of managing matrix teams in a regulated environment.
Key Responsibilities
- Lead all site operations, including production, quality control, engineering, and maintenance.
- Ensure compliance with current Good Manufacturing Practice (cGMP), GLP, and all regulatory requirements (MHRA, HSE, Environment Agency).
- Manage and develop a multidisciplinary team, including Production, QC, and Engineering Managers, ensuring effective staffing, training, and performance.
- Collaborate closely with Quality leadership, Qualified Persons (QPs), and QA teams to maintain robust Quality Management Systems (QMS).
- Oversee production planning and execution.
- Ensure site readiness and operational uptime, including plant, utilities, and critical infrastructure (e.g., air handling, power, gases).
- Lead maintenance and engineering activities, including fault resolution, contractor management, and spare parts control.
- Support new product introduction and validation activities, working cross-functionally with QA and technical teams.
- Act as deputy for the Head of Operations when required and represent the site in internal and external engagements.
Requirements
Essential
- Proven experience in pharmaceutical manufacturing environments.
- Strong working knowledge of GMP and regulatory compliance (MHRA or equivalent).
- Demonstrated experience managing matrix teams.
- Experience overseeing site operations, production processes, and maintenance systems.
- Strong leadership and organisational skills with the ability to drive performance and operational excellence.
- Experience with quality systems, SOPs, deviations, and compliance frameworks.
Desirable
- Experience in radiopharmaceuticals, aseptic or sterile manufacturing.
- Familiarity with cyclotron operations or PET/SPECT production environments.
- Experience supporting validation and new product introduction (NPI).
- Prior involvement in regulatory inspections or audits.