Head of Quality

Location: Hertfordshire

Our client is a leading provider of clinical research and life science solutions to the sector. Its Cambridge facility supports production, research and development, customer training, and product demonstrations. They are seeking a Head of Quality to lead the Quality function and maintain an effective, inspection-ready Quality Management System that supports regulatory compliance, product quality, continuous improvement, production and cross-functional operational excellence .

Responsibilities Lead, develop, and mentor the Quality team, setting clear objectives, accountabilities, and performance expectations Ensure the Quality Management System is established, implemented, maintained, and continually improved in line with applicable regulatory and GxP requirements Provide Quality Operations oversight across the organisation, ensuring compliant processes, documentation, equipment, environment, people, and product release decisions Promote continuous improvement through quality metrics, KPIs, trend analysis, risk management, CAPA, deviation management, change control, and audit findings Maintain inspection and audit readiness, supporting regulatory inspections and external audits by coordinating responses and presenting QMS information Partner with Operations, Regulatory Affairs, R&D, Medical Affairs, Commercial, IT, Manufacturing, Supply Chain, and other functions to embed compliant and sustainable quality practices Influence stakeholders to adopt quality system improvements, including eQMS enhancement programmes and future electronic batch record developments Essential:
Scientific, quality, regulatory, technical, or related experience in a pharmaceutical, biotechnology, clinical research, medical device, or similarly regulated environment Working knowledge of quality management systems, GxP expectations, Good Documentation Practice, ALCOA principles, electronic systems, and inspection/audit readiness Experience using quality metrics, KPIs, risk-based approaches, and continuous improvement tools to assess QMS performance and drive effective action

Experience with an electronic Quality Management System Ability to lead, collaborate cross-functionally, and influence stakeholders Desirable (not deal breakers):
Knowledge of IVD, CDx, IVDR, FDA 21 CFR, process validation, equipment validation, and computer systems validation requirements Technical or scientific knowledge relating to the manufacture, commercialisation, and distribution of regulated diagnostic or medical device products