Head of Quality

• 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.

• Manages the Quality Control and Assurance Service ensuring compliance with national standards and statute.
• Supports the Managing Director in setting the strategic direction for the Quality Control and Assurance Service.
• Actively contributes to the development of the annual business plan and strategic planning for HPS.
• Ensures that the Quality Control and Assurance Service fulfils HPSs objectives and is provided within allocated financial resources.
• When required to and related to quality aspects, contributes to the writing and assessment of product dossiers being developed for submission to regulatory authorities (e.g. the MHRA) for new product licences.
• Undertakes the following responsibilities for sterile and non-sterile pharmaceutical. manufacturing, aseptic manufacturing and extemporaneous product manufacture as outlined in the Rules and Guidance for Pharmaceutical Manufacture (GMP):
• To approve or reject starting materials, packaging and intermediate bulk and finished products
• To evaluate batch records
• To ensure that all necessary testing is carried out
• To approve specifications, sampling instructions, test methods and other QC procedures
• To approve and monitor any contract analysts
• To check the maintenance of the QC laboratory and equipment
• To ensure that appropriate validations are performed
• To co-ordinate and perform self-inspections of all manufacturing areas
• To deal with complaints from external customers relating to products supplied by HPS.
• To act as the internal investigation co-ordinator for HPS.
• Undertakes the following shared responsibilities relating to quality with the Head of Production:
• The authorisation of written procedures
• The monitoring and control of the sterile, non-sterile and aseptic manufacturing environments
• Plant hygiene
• Process validation
• Training
• The approval and monitoring of suppliers and contract manufacturers
• The designation and monitoring of storage conditions for medicines and raw materials used in the production unit.
• The retention of records
• The monitoring of compliance with the requirements of GMP
• To monitor factors which may affect product quality
• Is responsible for ensuring that all HPS manufacturing licences are maintained, and that any non-compliances arising from regulatory inspections are addressed within the timescales agreed with the medicines regulator (MHRA).
• Acts as the responsible Person in regard to all aspects of Good Distribution Practice for all operations undertaken by HPS.
• Ensures that all other legislation that impacts on the service is prioritised and complied with e.g. Health and Safety, Environmental issues, COSHH, CLP, etc.
• Is responsible, in co-operation with the Managing Director, for the development of new production control systems and the development of new or modified formulations.
• Leads on and works in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions (CAPAs), as applicable according to SOPs.
• Collaborates on and contributes to development projects, both initiated internally by HPS and externally by HPS customers.
• Is responsible for creating, monitoring and delivering Quality Control and Assurance based key performance indicators (KPIs) and ensures all routine work and projects are delivered on cost and on time.
• Is responsible for, and provides advice and guidance on, the implementation of the COSHH regulations.
• Undertakes quality assurance audits for all sections of HPS.
• Ensures there is a continuous improvement program to optimise processes.
• Is responsible for the provision of environmental monitoring for HPS.
• Is responsible for the recruitment and selection of staff working within Quality Control and Assurance departments.
• Implements Trust human resource policies in relation to the Quality Control and Assurance Service and undertakes sickness and absence, capability and disciplinary reviews.
• Is responsible for the management of the staffing budget for the Quality Control and Assurance service and advises the Managing Director on resource requirements for service provision.
• Acts as an authorised signatory within HPS of delegated authority.
• Continually reviews and improves the quality and standard of service provision through consultation with users of the Quality Control and Assurance service.
• Develops and maintains policies, procedures and records for the Quality Control and Assurance service.
• Ensures the appropriate stock control and storage of materials and safe maintenance of equipment used in the provision of the services managed by the post holder.
• Ensures that all staff working in services managed by the post holder are competent to perform their duties, receive appropriate training, an annual appraisal and personal development plan.
• Is responsible for the management of risk in relation to services managed by the post holder.
• In collaboration with the Managing Director, develops a culture that encourages the use of initiative, individual and team responsibilities, open communication and a corporate approach to decision making which takes into account HPS priorities.
• Develops and maintains working relationships with users and customers of HPS and Quality Control and Assurance services to continually improve the quality and standard of service provided.
• Attends and represents HPS at regional and local Quality Control and Assurance and technical services meetings, and if necessary, NHS national working groups.
• Covers the duties of other senior staff during periods of sickness and absence and undertakes any other reasonable duties including weekend provision of services.
• Alongside other colleagues, participates in an on-call service to ensure that manufacturing and Quality Control and Assurance operations are adequately maintained on a continuous basis.
• Prepares routine and ad-hoc board reports.

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

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

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