Our client is a leading provider of clinical research and diagnostic solutions for the life sciences sector. The Cambridge facility supports production, research and development, distribution, customer training, and product demonstrations.
They are seeking a Quality Manager to lead the Quality function across the site (reporting to the group Director) and maintain an effective, inspection-ready Quality Management System that supports regulatory compliance, product quality, continuous improvement, 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 site, ensuring compliant processes, documentation, equipment, environment, people, systems and product release decisions
- The Quality Manager will 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 requirements
- The Quality Manager will have either scientific, quality, regulatory, technical, or related experience in a pharmaceutical, biotechnology, IVD, 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 experience (not deal breakers)
- Knowledge of IVD, CDx, IVDR, FDA 21 CFR, process validation, equipment validation, and computer systems validation (CSV)
- Technical or scientific knowledge relating to the manufacture, commercialisation and distribution of regulated diagnostic or medical device products
Pay: £50,000.00-£60,000.00 per year
Benefits:
- Company car
- Company pension
- Cycle to work scheme
- Employee discount
- Free flu jabs
- On-site parking
- Private dental insurance
- Private medical insurance
- Sick pay
Work Location: In person
