Quality Systems Manager — GxP & eQMS Lead

Immunocore; Oxford; On-site; GBP 60,000 - 90,000; Full time

Job summary

Immunocore, Oxford, is seeking a Quality Systems Manager to own and improve QMS processes, ensuring compliance and continuous improvement across IT and business users. You will provide expert guidance and lead cross-functional workstreams to sustain inspection readiness and robust quality metrics.

The role requires 5+ years in a GxP environment, experience with eQMS systems, and strong communication skills.

Qualifications

• Bachelor’s degree in a scientific, quality, regulatory, or related discipline with typically 5+ years of relevant experience.
• Significant experience in a GxP-regulated environment, with demonstrated knowledge of quality management systems, electronic systems, regulatory expectations, and inspection/audit readiness.
• Demonstrated experience applying quality metrics, KPIs, trend analysis, and risk-based approaches to assess QMS performance and drive continuous improvement.
• Experience with at least one eQMS, such as Veeva, MasterControl, TrackWise, or equivalent.
• Working knowledge of Good Documentation Practice and ALCOA+ data integrity principles.
• Demonstrated ability to collaborate with cross-functional teams, foster support, and influence stakeholders across the company.
• Excellent proven written and oral communication skills
• Intermediate Microsoft Office skills, including Word, Excel, PowerPoint, and Outlook.

Responsibilities

• Provide subject matter expertise and leadership for assigned QMS processes and electronic workflows, partnering with Quality Systems colleagues, IT, system owners, vendors, and business users to support compliant, effective, and validated operation.
• Understand interdependencies between Quality Assurance, IT, Regulatory, Clinical, Manufacturing, Supply Chain, and other 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 clearly to management and stakeholders.
• Lead or support the design, implementation, monitoring, and continuous improvement of assigned QMS processes, including development and maintenance of 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 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.

Skills

Cross-functional collaboration

Written and oral communication

Quality management systems

GxP knowledge

Education

Bachelor's degree in science/quality/regulatory

Tools

Veeva

MasterControl

TrackWise

Job description

Immunocore, Oxford, is seeking a Quality Systems Manager to own and improve QMS processes, ensuring compliance and continuous improvement across IT and business users. You will provide expert guidance and lead cross-functional workstreams to sustain inspection readiness and robust quality metrics.

The role requires 5+ years in a GxP environment, experience with eQMS systems, and strong communication skills.