Job summary
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
- Provide strategic and professional leadership for QA and QC services across both Trusts
- Act as Quality Controller on MHRA Specials manufacturing license's for Pharmacy and Radio pharmacy
- Ensure robust, GMP-compliant quality systems support pharmaceutical and radiopharmaceutical manufacturing
- Provide expert assurance to senior management on regulatory compliance and inspection readiness
- Lead engagement with regulators, including the MHRA, and represent the Trusts during inspections and audits
- Oversee validation lifecycle management for facilities, equipment, processes and analytical methods
- Lead and develop multidisciplinary QA and QC teams across two Trusts, including workforce planning and training
- Champion research, innovation and clinical trials, ensuring QA/QC compliance with GMP and GCP
- Act as a senior advisor on pharmaceutical quality, patient safety, unlicensed medicines and risk management
- Manage budgets and resources for Quality Services in line with Trust governance and financial requirements
- Act as a senior leader across the pharmacy department and pharmacy senior leadership team
About us
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. .
Job description
Job 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.
Job description
Job 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
- Master's degree in pharmacy or in science-based discipline or equivalent experience
- Specialist higher diploma (Masters) in Technical Services (e.g. National course in Pharmaceutical Technology & Quality Assurance) or equivalent experience
Desirable
- Management qualification MBA
- Doctorate in relevant field
- EU Qualified Person status or eligible to be a QP or QP/IMP
Experience
Essential
- Extensive specialist knowledge & experience particularly in the manufacturing and release of: oSterile injectable manufacture oManufacture of Special (unlicensed) medicinal products oRadiopharmacy
- Extensive Quality Managerial experience in a specials / Licensed Pharmaceutical manufacturing facility and experience of hosting Regulatory and Corporate/Regional audits
- Previous role and experience as Person Responsible for Quality Control on the MHRA Specials manufacturing licence.
- 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.
- Extensive experience as a Releasing Officer for manufactured medicinal products in a specials / licensed manufacturing unit
- 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
- Experience of Research and supply of IMP medicines for clinical trials
Skills
Essential
- 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
- Demonstrated ability to identify and manage risks and ability to make quality-based decisions on batch disposition.
- Demonstrated evidence of being able to manage change with QA/Production services and to evaluate and improve service quality.
- Demonstrated expert knowledge of the validation requirements for pharmaceutical facilities, equipment, analytical procedures and products.
- Demonstrated good understanding of key NHS objectives and publications especially with regards to Specials Manufacturing.
Desirable
- 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.
Person Specification
Education
Essential
- Master's degree in pharmacy or in science-based discipline or equivalent experience
- Specialist higher diploma (Masters) in Technical Services (e.g. National course in Pharmaceutical Technology & Quality Assurance) or equivalent experience
Desirable
- Management qualification MBA
- Doctorate in relevant field
- EU Qualified Person status or eligible to be a QP or QP/IMP
Experience
Essential
- Extensive specialist knowledge & experience particularly in the manufacturing and release of: oSterile injectable manufacture oManufacture of Special (unlicensed) medicinal products oRadiopharmacy
- Extensive Quality Managerial experience in a specials / Licensed Pharmaceutical manufacturing facility and experience of hosting Regulatory and Corporate/Regional audits
- Previous role and experience as Person Responsible for Quality Control on the MHRA Specials manufacturing licence.
- 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.
- Extensive experience as a Releasing Officer for manufactured medicinal products in a specials / licensed manufacturing unit
- 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
- Experience of Research and supply of IMP medicines for clinical trials
Skills
Essential
- 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
- Demonstrated ability to identify and manage risks and ability to make quality-based decisions on batch disposition.
- Demonstrated evidence of being able to manage change with QA/Production services and to evaluate and improve service quality.
- Demonstrated expert knowledge of the validation requirements for pharmaceutical facilities, equipment, analytical procedures and products.
- Demonstrated good understanding of key NHS objectives and publications especially with regards to Specials Manufacturing.
Desirable
- 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.
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
