Head of Quality: Sponsorship Available

Job summary

Post description

• Is responsible for the strategic development and operational management of the Quality Control and Assurance Service ensuring compliance with current standards and statute.
• Responsible for all areas of the Quality function and provides support within operations.
• Lead and develop the Quality Management system.
• Is the named Quality Controller on HPS’s MHRA Manufacturer/importer licence (MIA), Specials Manufacturing and IMP Licences and undertakes the responsibilities outlined in the current edition of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors produced by the Medicines and Healthcare products Regulatory Agency (MHRA).
• Is the named Responsible Person (RP) on the Wholesale Dealer Authorisation (WDA(H)) licence and undertakes the responsibilities outlined in the Good Distribution regulations (GDP).
• Is a member of the HPS Senior Management Team assisting in the strategic development of the business and service.
• Leads on special projects as requested by The Managing Director.
• Provides emergency cover (out of hours) for HPS.

Main duties of the job

Managerial Duties

• Manages headcount in Quality Control and Assurance departments.
• Manages the Quality Control and Assurance Service ensuring compliance with national standards and statute
• Acts as the responsible Person in regard to all aspects of Good Distribution Practice for all operations undertaken by HPS.
• Is responsible for the management of risk in relation to services managed by the post holder.

Person Specification

QUALIFICATIONS / TRAINING

Essential

• Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology or equivalent. Full professional membership of a relevant professional body (e.g. MRPharmS, CChem)
• Eligible for nomination as a QP (as defined by the joint professional bodies)
• Relevant post graduate qualification e.g. PhD, Masters or Post graduate Diploma in Pharmaceutical Technology and Quality Assurance

Desirable

• Relevant post graduate qualification e.g. PhD, Masters or Post graduate Diploma in Pharmaceutical Technology and Quality Assurance
• Currently practicing as a QP

KNOWLEDGE, EXPERIENCE & EXPERTISE

Essential

• Substantial/significant experience QA/QC in QA/GMP environment/s at a high level which the post holder can relate to current NHS Manufacturing and Quality Assurance services.
• Expertise should include extensive development and management of Quality Management Systems
• A strong track record in preparing for, hosting and achieving satisfactory outcomes from regulatory GMP audits (MHRA / FDA)
• Experience in completing the quality sections of marketing authorisation applications that are submitted to medicine regulators in-order to obtain product licences
• Detailed knowledge and understanding of Pharmaceutical Manufacture, Good Manufacturing Practice, Good Distribution Practice and Good Control Laboratory Practice.
• Understanding of legislation relating to pharmaceutical manufacture
• Computer literacy
• Quality audits

Desirable

• Financial management
• Knowledge of ISO9000 Quality System
• Knowledge of product licensing and medical device registration

COMMUNICATION AND RELATIONSHIPS (INCLUDING MANAGEMENT RESPONSIBILITIES)

Essential

• Leadership and motivational skills
• Highly developed interpersonal and communication skills.
• Ability to prioritise workload and meet deadlines whilst paying attention to detail.
• Ability to work under pressure.
• Ability to work on own initiative and as part of a team.
• Self-motivating and able to motivate/inspire others
• Ability to influence and negotiate with managers, senior medical, nursing and pharmacy staff
• Planning and Organisational skills
• Able to effect and manage change
• Problem solving and analytical skills
• Education & Training skills

Closing Date: 20 September 2026