Job Overview
University Hospital Southampton NHS Foundation Trust offers a senior leadership role in pharmaceutical quality assurance at our state‑of‑the‑art aseptic facility, located in Southampton on the south coast with excellent transport links.
About This Role
As a Pharmaceutical Microbiologist and Deputy Head of Pharmacy Quality Assurance, you will ensure the safe manufacture of aseptic and radiopharmaceutical medicines that directly support patient care. You will work closely with the Head of Pharmacy Quality Assurance, provide strategic and operational leadership, deputise when required, and contribute to developing, delivering and continuously improving the Pharmaceutical Quality Management System (PQMS).
In addition, you will lead the Pharmacy Microbiology QC service, ensuring environmental monitoring and microbiological testing programmes are delivered in line with GMP and regulatory expectations. You will act as the department’s subject‑matter expert for microbiological contamination control, leading strategies, interpreting data and driving improvements in sterility assurance and compliance. A key aspect of the role is serving as the Quality Controller on the Radiopharmacy MHRA MS Licence, with accountability for quality and oversight of relevant systems and processes.
The role reports directly to the Head of Pharmacy Quality Assurance and includes line‑management responsibilities within the QA/QC microbiology team. It involves regular on‑site presence across manufacturing facilities, with flexibility as service needs allow. You will operate in a highly regulated GMP environment and lead through complexity, requiring strong leadership, influencing skills and deep industry knowledge.
Responsibilities
* Support the Head of Pharmacy Quality Assurance to lead and continuously improve the PQMS across licensed manufacturing services, including deputising when required.
* Lead the Pharmacy Microbiology QC service, ensuring environmental monitoring and microbiological testing programmes are delivered, trended and acted upon in line with GMP and regulatory requirements.
* Act as subject‑matter expert for contamination control, leading strategies, reviewing data and driving improvements in sterility assurance and compliance.
* Serve as the Quality Controller on the Radiopharmacy MHRA MS Licence and provide oversight of quality systems, supporting inspection readiness and regulatory compliance across services.
Requirements
* Significant experience in pharmaceutical microbiology, quality assurance and/or quality control within an MHRA‑licensed manufacturing environment.
* Strong knowledge of GMP, regulatory requirements and experience in environmental monitoring, contamination control and interpretation of microbiological data.
* Proven leadership and people‑management skills, experience supervising teams, influencing practice and driving service improvement in a complex environment.
* Strong analytical and problem‑solving skills, ability to assess risk, investigate deviations and implement effective corrective and preventative actions.
* Ability to work across UHS pharmacy manufacturing sites, including aseptic and radiopharmacy services, with regular on‑site presence and travel between locations.
* Appointment will require suitability to be named on an MHRA Manufacturer’s Licence (subject to approval).
Person Specification
* Essential criteria: Patients First, Always Improving, Working Together.
* Qualifications: Bachelor of Science degree in microbiology or relevant science degree; Master’s degree in microbiology or equivalent experience; Significant experience in QC/QA in hospital or industrial environment, including MHRA licensed manufacturing.
* Practical knowledge of cGMP, G(QC)LP, PQMS, QA and current legislation; training & supervising staff; knowledge of formulation, stability and manufacturing processes.
* Desirable criteria: Full membership of a relevant professional body, radiopharmacy qualification or experience, higher‑level management training, previous leadership role in sterile product manufacture, project management certification.
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