QA Manager - Hays Specialist Recruitment Limited : Job Details

Your new companyAn innovative biotech start-up is pushing the boundaries of immune profiling and precision diagnostics using AI and machine learning. Backed by cutting-edge research and a collaborative, cross-functional team, this company is dedicated to transforming the way immune-related diseases are understood and treated. They're growing fast and looking for mission-driven individuals ready to make an impact.Your new roleAs Quality Manager, you'll take ownership of the Quality Management System (QMS), ensuring full compliance with ISO 13485 and associated regulatory standards. You'll lead internal and external audits, drive CAPA implementation, manage documentation and validation processes, and promote continuous improvement across quality systems. This is a full-time, office-based role (minimum 3 days per week on site) with occasional international travel.What you'll need to succeed

• Hands-on experience managing ISO 13485:2016 compliant QMS
• Strong knowledge of risk management (ISO 14971), GCLP, CAPA, and validation (IQ/OQ/PQ)
• Background in biotech, biomedical science, immunology, or similar
• Solid understanding of regulatory submissions and eQMS platforms
• Confident communicator and proactive team player with excellent problem-solving skills
• Experience training others on quality procedures and compliance

Desirable: M.Sc./PhD, flow cytometry knowledge, quality certifications, previous start-up experience.What you'll get in return

• Competitive salary based on experience
• Bonus scheme eligibility
• Career progression in a fast-paced, high-growth biotech environment
• Opportunity to shape and scale the QMS from within
• Exposure to groundbreaking science and multidisciplinary collaboration

What you need to do nowIf you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.