Job overview
We are seeking an experienced and exceptional Head of Pharmaceutical Quality to provide strategic leadership for Quality Assurance (QA) and Quality Control (QC) services across ICHT and LNWUH.
This senior, cross-Trust role holds overall responsibility for pharmaceutical and radio pharmacy quality systems, ensuring compliance with MHRA Specials and IMP manufacturing license's. QA/QC Services provided are across aseptics, sterile and non-sterile manufacture, pre-packing, radio pharmacy, and advanced medical therapies. The post holder will act as Quality Controller, providing assurance to Trust Boards and senior leadership on regulatory compliance, inspection readiness and patient safety.
This is a rare opportunity to shape pharmaceutical quality services at scale within two leading NHS Trusts, with strong links to research, innovation and regional collaboration.
Main duties of the job
1. Provide strategic and professional leadership for QA and QC services across both Trusts
2. Act as Quality Controller on MHRA Specials manufacturing license's for Pharmacy and Radio pharmacy
3. Ensure robust, GMP-compliant quality systems support pharmaceutical and radiopharmaceutical manufacturing
4. Provide expert assurance to senior management on regulatory compliance and inspection readiness
5. Lead engagement with regulators, including the MHRA, and represent the Trusts during inspections and audits
6. Oversee validation lifecycle management for facilities, equipment, processes and analytical methods
7. Lead and develop multidisciplinary QA and QC teams across two Trusts, including workforce planning and training
8. Champion research, innovation and clinical trials, ensuring QA/QC compliance with GMP and GCP
9. Act as a senior advisor on pharmaceutical quality, patient safety, unlicensed medicines and risk management
10. Manage budgets and resources for Quality Services in line with Trust governance and financial requirements
11. Act as a senior leader across the pharmacy department and pharmacy senior leadership team
Working for our organisation
At Imperial College Healthcare you can achieve extraordinary things with extraordinary people, working with leading clinicians pushing boundaries in patient care.
Become part of a vibrant team living our values - expert, kind, collaborative and aspirational. You’ll get an experience like no other and will fast forward your career.
Benefits include career development, flexible working and wellbeing, staff recognition scheme. Make use of optional benefits including Cycle to Work, car lease schemes, season ticket loan or membership options for onsite leisure facilities.
We are committed to equal opportunities and improving the working lives of our staff and will consider applications to work flexibly, part time or job share. Please talk to us at interview. .
Detailed job description and main responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role and the person specification outlines the qualifications, skills, experience and knowledge required. For both overviews please view the Job Description attachment with the job advert.
Person specification
Education
Essential criteria
12. Master’s degree in pharmacy or in science-based discipline or equivalent experience
13. Specialist higher diploma (Masters) in Technical Services (e.g. National course in Pharmaceutical Technology & Quality Assurance) or equivalent experience
Desirable criteria
14. Management qualification MBA
15. Doctorate in relevant field
16. EU Qualified Person status or eligible to be a QP or QP/IMP
Experience
Essential criteria
17. Extensive specialist knowledge & experience particularly in the manufacturing and release of: oSterile injectable manufacture oManufacture of Special (unlicensed) medicinal products oRadiopharmacy
18. Extensive Quality Managerial experience in a specials / Licensed Pharmaceutical manufacturing facility and experience of hosting Regulatory and Corporate/Regional audits
19. Previous role and experience as Person Responsible for Quality Control on the MHRA Specials manufacturing licence.
20. Significant experience in the design, building and commissioning and validation of equipment, new or major upgrade of Production facilities or QC Laboratory, and manufacturing processes.
21. Extensive experience as a Releasing Officer for manufactured medicinal products in a specials / licensed manufacturing unit
22. Highly effective leadership including previous evaluated experience of coaching junior QA staff, mentorship and training skills, in addition to a strong track record in engaging with and influencing senior decision makers
Desirable criteria
23. Experience of Research and supply of IMP medicines for clinical trials
Skills
Essential criteria
24. Demonstrated expert knowledge of GCP, GMP, GLP, QA and all current relevant regulations plus technical knowledge of pharmaceutical QA and GMP with a proven ability to apply this knowledge to develop and maintain quality systems
25. Demonstrated ability to identify and manage risks and ability to make quality-based decisions on batch disposition.
26. Demonstrated evidence of being able to manage change with QA/Production services and to evaluate and improve service quality.
27. Demonstrated expert knowledge of the validation requirements for pharmaceutical facilities, equipment, analytical procedures and products.
28. Demonstrated good understanding of key NHS objectives and publications especially with regards to Specials Manufacturing.
Desirable criteria
29. 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.
Right to work
If you need sponsorship to work in the UK, please visit the Home Office website for information on sponsorship and visa status before you fill in your application form. Due to recent changes in the UK immigration rules which affect Skilled Worker Visas, Global Business Mobility, Higher Skill Level and Increased Salary Thresholds, please ensure that you are able to meet the requirements to live and work in the UK before applying. Further information about eligibility is available on
Please ensure you check your emails regularly as this is how we will communicate with you throughout the recruitment process. If you are shortlisted you will be contacted by email and text message (if you provide a mobile contact number).
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