Quality Manager - Start-up Biotech

ZipRecruiter; London; On-site; GBP 40,000 - 60,000; Full time

Job summary

An innovative biotech start-up in London is seeking a Quality Manager to lead their Quality Management System and ensure compliance with ISO 13485. This full-time, office-based role offers a competitive salary and the chance to enhance QMS practices in a fast-paced, collaborative environment.

Benefits

Competitive salary based on experience

Bonus scheme eligibility

Career progression in a biotech environment

Opportunity to shape the QMS

Qualifications

• Hands-on experience managing ISO 13485:2016 compliant QMS.
• Strong knowledge of risk management (ISO 14971), GCLP, CAPA, and validation.
• Background in biotech, biomedical science, immunology, or similar.

Responsibilities

• Take ownership of the Quality Management System (QMS) ensuring compliance with ISO 13485.
• Lead internal and external audits and manage documentation and validation processes.
• Promote continuous improvement across quality systems.

Skills

Risk management

Problem-solving

Communication

Education

M.Sc./PhD in relevant field

Job description

Job Description

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
• 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 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.

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