Medical Device Quality Inspector jobs

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

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.

Key Responsibilities:

• 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.

Education, Experience and Knowledge:

Essential Qualifications:

• Bachelor's degree in a scientific, quality, regulatory, technical, or related discipline with typically 5+ years of relevant experience in the pharmaceutical, biotechnology, clinical research, or similarly regulated industry; or equivalent combination of education and experience.
• Significant experience working 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.

Non-Essential Qualifications:

• Working familiarity with two or more eQMS systems (e.g., MasterControl, Veeva, TrackWise)
• Knowledge of computer systems validation (CSV) in the pharmaceutical/biopharma industry
• Knowledge of the clinical trial/drug development process and/or drug commercialisation
• Technical and/or scientific knowledge related to biopharmaceutical drug development, clinical research, manufacture or distribution.