QA Manager

Hays; London; On-site; GBP 36,000 - 42,000; Full time

Job summary

Join an innovative biotech start-up as a Quality Manager and play a key role in ensuring compliance with ISO standards. Work with a dynamic team dedicated to transforming treatments for immune-related diseases. Opportunities for career progression and shaping quality procedures, while being involved in cutting-edge science.

Benefits

Competitive salary based on experience

Career progression in a fast-paced environment

Exposure to groundbreaking science

Qualifications

• Hands-on experience managing ISO 13485 compliant QMS.
• Strong knowledge of risk management techniques.
• Experience training others on quality procedures.

Responsibilities

• Oversee and ensure compliance with QMS regulations.
• Lead internal and external audits.
• Promote continuous improvement in quality systems.

Skills

ISO 13485:2016 compliance management

Risk management

Problem-solving

Education

M.Sc./PhD in related field

Job description

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This range is provided by Hays. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing and Biotechnology Research

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