Job summary
We are looking for an experienced, 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 and radiopharmacy.
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 experienced quality professional with extensive specialist knowledge & experience of sterile and non sterile pharmaceutical specials manufacture with experience 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.
For informal visits or to discuss the role / site in more detail do contact us to find out more information.
Previous candidates need not re-apply
Main duties of the job
- 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
About us
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
Job description
Job responsibilities
Key areas of responsibility:
Professional Leadership
Policy and Planning
Regulatory Compliance
Quality System Management
Quality Assurance / Quality Control
Lifecycle Management
Job description
Job responsibilities
Key areas of responsibility:
Professional Leadership
Policy and Planning
Regulatory Compliance
Quality System Management
Quality Assurance / Quality Control
Lifecycle Management
Person Specification
Knowledge
Essential
- Masters degree in pharmacy (MPharm), Masters degree in science based discipline or equivalent experience
- Extensive specialist knowledge & experience of release of Sterile injectable medicines, Special (unlicensed) medicinal products
Previous experience
Essential
- Ability to apply highly complex technical knowledge and understanding to making appropriate and timely risk based decisions under high pressure
- Quality Managerial experience in a specials / sterile licensed pharmaceutical manufacturing facility
- Experience of Research and supply of IMP medicines for clinical trials
- Experience of validation of pharmaceutical equipment, facilities and processes
- Experience of hosting Regulatory and Corporate/Regional audits
Knowledge
Essential
- Demonstrated ability to ensure quality through the set up, manufacturing and release of IMPs under a MAIMP to comply fully with the requirements of GMP and GCP
- Demonstrated expert technical knowledge of pharmaceutical QA and GMP and a proven ability to apply this knowledge to develop and maintain quality systems
- Demonstrated expert knowledge of the validation requirements for pharmaceutical facilities, equipment, analytical procedures and products.
Person Specification
Knowledge
Essential
- Masters degree in pharmacy (MPharm), Masters degree in science based discipline or equivalent experience
- Extensive specialist knowledge & experience of release of Sterile injectable medicines, Special (unlicensed) medicinal products
Previous experience
Essential
- Ability to apply highly complex technical knowledge and understanding to making appropriate and timely risk based decisions under high pressure
- Quality Managerial experience in a specials / sterile licensed pharmaceutical manufacturing facility
- Experience of Research and supply of IMP medicines for clinical trials
- Experience of validation of pharmaceutical equipment, facilities and processes
- Experience of hosting Regulatory and Corporate/Regional audits
Knowledge
Essential
- Demonstrated ability to ensure quality through the set up, manufacturing and release of IMPs under a MAIMP to comply fully with the requirements of GMP and GCP
- Demonstrated expert technical knowledge of pharmaceutical QA and GMP and a proven ability to apply this knowledge to develop and maintain quality systems
- Demonstrated expert knowledge of the validation requirements for pharmaceutical facilities, equipment, analytical procedures and products.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
