Agenda for Change (Afc) Band 8b equivalent
Pay scales for 2026/27 | NHS Employers

Main Duties and Responsibilities:

The following apply either across all workstreams within smaller Section 10 units (e.g. combined anti-cancer therapy and CIVAS services) or to a specific workstream within larger Section 10 units or licensed services (e.g. parenteral nutrition only). ^*1

Microbial Testing and Analysis

• Lead the design of sterility testing validation methods and associated strategies
• Establish and oversee sterility assurance approaches in line with regulatory expectations

Environmental Monitoring and Equipment Validation

• Review and approve validation documentation for equipment and facilities, including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ)

Testing and Quality Control

• Approve programmes of testing, including protocols, methods, frequencies and acceptance criteria
• Approve temperature mapping strategies and outcomes
• Deputise for approval of analytical method validation where required

Pharmaceutical Quality System (PQS) and Quality Management

• Provide strategic oversight and evaluate the effectiveness of PQS processes, including deviations, corrective and preventative actions (CAPA) and change control
• Perform quality assurance evaluation of out-of-specification (OOS) investigations, including approval of re-testing and final closure
• Review and approve validation documentation and associated non-conformances
• Review and approve calibration certification for equipment and consumables
• Approve validation programmes and individual validation projects
• Approve audit reports and associated action plans
• Lead external and supplier audits and oversee delivery of audit programmes
• Develop audit tools and maintain the audit schedule
• Review and approve the Validation Master Plan (VMP), Site Master File (SMF) and Quality Manual (QM)
• Review and approve the Contamination Control Strategy (CCS)
• Support strategic development and oversight of the PQS, including review and approval of quality data trends and critical documentation
• Act as a senior point of contact for regulatory authorities (e.g. MHRA), overseeing inspection readiness and ensuring effective implementation of CAPAs in response to inspections, complaints, errors and incidents

 Training, Supervision and Development

• Provide oversight of internal and external training programmes
• Undertake line management of senior staff and provide leadership across the quality function

 Stock and Inventory Management

• Review and approve quality-related technical agreements (TAs) and service level agreements (SLAs)
• Approve procurement of high-cost equipment and contribute to budget management

Customer and Stakeholder Interaction

• Develop and maintain robust systems to mitigate the risk of falsified medicines entering the supply chain
• Chair quality review meetings and contribute to governance forums, including relevant committees (e.g. Medical Gas Committee)

Operational and Administrative Duties

• Provide governance and oversight for medical gases policy and associated frameworks
• Develop and maintain the Standard Operating Procedure (SOP) master plan and approve standardised documentation templates
• Provide final authorisation of validation outcomes and reports
• Lead comprehensive, system-wide audits against regulatory and professional standards

Medical Gases Pipeline Systems (MGPS)

• Provide strategic oversight of medical gas testing programmes and procurement quality assurance processes
• Review and approve medical gas testing reports
• Oversee training and competency frameworks related to medical gas testing

Leadership and Service Management

• Support complex workforce management activities, including participation in formal HR processes
• Hold accountability for the delivery, governance and strategic direction of QC and QA services
• Ensure delivery of a safe and effective service, prioritising activity in response to capacity constraints and negotiating with stakeholders as required
• Review and approve business cases for service development and expansion
• Oversee the monitoring and review of capacity and contingency plans
• Provide strategic oversight of service development and improvement initiatives, including the introduction of new technologies and systems
• Lead the development, review and refinement of key performance indicators (KPIs)
• Lead research and innovation activities within the department and wider organisation
• Represent the service at organisational, regional and national level as a key stakeholder