Manager, Quality Systems

Location of role Oxford, UK
Department Clinical QA

Key Responsibilities The Quality Systems Manager owns and provides subject matter expertise for assigned QMS processes within Immunocore’s overall Quality Management System, ensuring they remain effective, compliant, risk-based, and continuously improving. Assigned QMS processes may include audit programme management, supplier quality management, document management, deviation/CAPA management, change control, training, or other quality system processes as required.
Applying advanced knowledge of GxP requirements, regulatory expectations, quality management principles, and company procedures, the Quality Systems Manager supports the design, implementation, maintenance, monitoring, and improvement of assigned QMS processes. The role provides expert guidance to cross-functional stakeholders, supports inspection and audit readiness, contributes to quality objectives and continuous improvement initiatives, and uses quality data and metrics to identify risks, recommend improvements, and drive compliant, sustainable solutions.
Working collaboratively with Quality leadership, colleagues, process owners, system owners, IT, and business process users, the role supports effective use and ongoing improvement of quality systems and associated electronic platforms. The Quality Systems Manager is expected to operate with independence on complex matters, communicate effectively with management and peer groups, influence stakeholders across disciplines, and provide coaching, guidance, and support to colleagues and system users.

• Provide subject matter expertise and functional leadership for assigned QMS processes and associated electronic system workflows, partnering with Quality Systems colleagues, IT, system owners, vendors, and business users to support compliant, effective, and validated operation.
• Understand and consider the interdependencies between Quality Assurance, IT, Regulatory, Clinical, Manufacturing, Supply Chain, and other relevant functions when developing or improving quality system processes.
• Lead or contribute to cross-functional meetings, workshops, and working groups, communicating complex quality system concepts, risks, metrics, and recommendations related to QMS governance, improvement, inspection readiness, and process effectiveness clearly to management, peer groups, and stakeholders across disciplines.
• Lead or support the design, implementation, monitoring, and continuous improvement of assigned QMS processes, including development and maintenance of associated SOPs, work instructions, guidance documents, and supporting documentation.
• Analyse quality system data, metrics, trends, and QMS Review inputs to assess performance, identify risks and improvement opportunities, and recommend or drive pragmatic, compliant, and sustainable actions.
• Support Quality Systems during regulatory inspections and external audits, providing expert input, presenting QMS information clearly, coordinating responses, and supporting timely resolution of inspection or audit-related requests.
• Develop and implement training strategies and plans for eQMS users across Immunocore and for external users, including onboarding of new starters.
• Provide guidance, coaching, and knowledge sharing to colleagues, system users, and less experienced personnel, supporting capability building and consistent application of quality system requirements.
• Provide expert quality systems input into the review, escalation, and timely closure of Deviations, CAPA, Change Control, audit findings, and other quality records, applying sound judgement to ensure appropriate root cause evaluation, risk assessment, corrective action planning, and effectiveness monitoring.
• Maintain advanced knowledge of applicable GxP regulations, regulatory guidance, industry expectations, and quality system best practice, applying this knowledge to inform policy, process, and system improvements.
• Influence stakeholders across disciplines to adopt compliant, effective, and sustainable quality system practices.
• At the direction of Line Manager, supports Due Diligence and ad hoc requests, as needed.