QA Manager

JR United Kingdom; London; On-site; GBP 40,000 - 70,000; Full time

Job summary

A leading biotech start-up is seeking a Quality Manager to oversee the Quality Management System (QMS) and ensure compliance with regulatory standards. This role, which includes leadership of audits and quality assurance processes, offers an exciting opportunity to contribute to innovative research in immune profiling and precision diagnostics.

Benefits

Career progression opportunities

Exposure to groundbreaking science

Flexible working arrangements

Qualifications

• Hands-on experience managing ISO 13485:2016 compliant QMS.
• Strong knowledge of GCLP and CAPA.
• Experience training others on quality procedures.

Responsibilities

• Take ownership of the Quality Management System, ensuring compliance.
• Lead internal and external audits.
• Drive CAPA implementation and promote continuous improvement.

Skills

Risk management

Problem-solving

Communication

Teamwork

Education

M.Sc./PhD in related field

Tools

eQMS platforms

Job description

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Your new company
An 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 role
As 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
• 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 now
If 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.