Head of Pharmaceutical Quality

1 day ago

London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

We are looking for an experience, dynamic and innovative Head of Quality who will be the senior quality professional for the Trust's Pharmaceutical Technical services department. The department consists of 130 staff and includes sterile and non sterile manufacture, aseptic preparation and the manufacture and dispensing of investigational medicinal products. You will be named head of quality of the specials and IMP licence for pharmacy, radiopharmacy and the faecal microbiota transplantation.

You will ensure a comprehensive, compliant and high level Quality service and direct and oversee the activities of the Quality Assurance team (17staff), Quality Control laboratory (7 staff), Pharmaceutical Life Cycle team (5 staff) and the lead QP.

You will be an experience quality professional with extensive specialist knowledge & experience of sterile and non sterile pharmaceutical specials manufacture withexperience or capacity to gain experience in(FMT),Radiopharmacy and IMPs. You will need to demonstrate the ability to lead and develop a diverse team of people to ensure they perform to the highest standards and be a role model in placing quality at the centre of the department.
- To provide strategic direction, leadership and the development of Pharmaceutical QA and QC Services to the Trust and to external customers of the Trust, to meet local, regional and nationally agreed requirements and priorities
- To perform the role of Quality Controller as nominated on the MHRA specials and IMP manufacturing licenses for pharmacy, radiopharmacy and faecal microbiota transplantation (FMT) sites
- To provide assurance to senior management of ongoing and future regulatory compliance status of the activities covered by the role and escalate compliance concerns to senior management
- To ensure that a GMP compliant Quality System is in place to support manufacturing under specials and IMP manufacturing licenses. To be responsible for developing and managing integrated Quality Systems across the pharmacy, radiopharmacy and FMT and those operating under Section 10 exemption.
- To be responsible for QA and QC advice and support necessary for the management of Clinical Trials in the Pharmacy in accordance with the statutory requirements for GCP and GMP.
- To manage Lifecycle Management activities to ensure compliance with required standards
- To manage and direct the activities of the lead Qualified Person

GSTT Pharmaceuticals manufactures and prepares unlicensed medicines and clinical trial products under Manufacturer’s “Specials” and Investigational Medicinal Product licences as well as licence exemptions. Working with leading clinicians at Guy’s and St Thomas' Hospital, we develop and manufacture new medicines and novel formulations to meet clinical needs, reduce risk of ward based preparation, standardise treatments and support clinical research. The manufacturing team is able to meet bespoke orders, including a wide range of non-sterile, sterile and aseptic products with onsite production, quality control and quality assurance services

**Key areas of responsibility**:
Professional Leadership

Policy and Planning

Regulatory Compliance

Quality System Management

Quality Assurance / Quality Control

Lifecycle Management

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