Director, Quality & Compliance

bit.bio is an award-winning spinout from the University of Cambridge. Our breakthrough technology combines synthetic and stem cell biology for the precise, efficient and consistent reprogramming of human cells used in research, drug discovery, and cell therapy. At bit.bio, we are passionate about engineering human cells that will enable the medicine of the future. To do this we need talented and curious people who want to make an impact on the future of science and therapeutics.

As a team of individuals, we value science, collaboration, openness, curiosity and creativity. We are united by trust and respect for each other.

Location: Babraham Research Campus, Cambridge

Type: Full time, permanent / Start: Immediate

Salary: Competitive / Hours: 40 p/w

Office Based Position: Hybrid working available

Your role in our team:

Reporting to the VP, Operations, the Director, Quality & Compliance will lead and drive the execution of bit.bio's quality strategy across the entire product lifecycle - from research and development to launch, commercialization, and ongoing lifecycle management for Research Use Only (RUO) products.

As the organisational lead for Quality & Compliance, this role will be responsible for developing, implementing and maintaining a robust Quality Management System (QMS) that supports research product programmes while ensuring compliance with national and international regulatory requirements. The Director will play a critical role in embedding a culture of quality and continuous improvement, enabling bit.bio to meet the highest standards in product excellence and regulatory compliance.

Your key responsibilities will include:

1. Lead and maintain Quality & Compliance programmes, policies, and procedures for RUO product quality and compliance.
2. Ensure adherence to international regulations, including ethical, labelling, and customs requirements.
3. Develop and implement compliance strategies aligned with business and regulatory needs.
4. Act as the figurehead for quality and continuous improvement within the organisation.
5. Lead and manage teams to develop new methods and solve complex quality challenges.
6. Oversee internal and external audits, supplier qualification, and change/issue management.
7. Own and maintain the electronic quality management system (eQMS).
8. Develop and implement company-wide training and competency strategies.
9. Drive product and process quality through effective quality systems and supplier oversight.
10. Lead management and product review meetings, ensuring compliance with data integrity standards.
11. Manage the customer-facing document library to meet customer and regulatory expectations.
12. Represent Quality & Compliance in project teams, business audits, supplier engagements, and QA meetings.

You

Have a minimum Degree in a relevant scientific discipline (e.g., Life Sciences, Chemistry, Biotechnology) or equivalent industry experience.

Have significant experience in quality and compliance management within a Life Sciences regulated environment.

With essential experience in

1. Proven experience leading a GxP-oriented Quality & Compliance function in a pharmaceutical or biotechnology company, including line management.
2. Strong knowledge of manufacturing and quality processes, particularly for biologicals or vaccine products.
3. Extensive experience in Quality Management Systems (QMS) development and application using a risk-based approach.
4. Experience hosting business audits and conducting/overseeing compliance audits.
5. Skilled in supplier qualification and supplier management, ensuring quality standards are met.
6. Experience in management, leadership and team development, with a track record of forming and retaining high-performing teams.
7. Ability to lead process and system improvements with minimal guidance, including interpreting and modifying company-wide policies and procedures.
8. Hands-on experience in manufacturing and/or analytical testing & development.
9. Proven ability to make timely and sound quality decisions in complex supply, compliance, technical, and regulatory environments.
10. Strong problem-solving and analytical skills, with the ability to work with ambiguity and complexity.
11. Experience successfully leading cross-functional teams and ensuring multi-dimensional project delivery.
12. Excellent verbal and written communication skills, with a team-oriented mindset and ability to influence at all levels.
13. Strong business acumen, ensuring budgets and schedules meet corporate requirements.
14. Ability to work independently, set priorities, and meet deadlines, with prior management experience required.

and possibly

Experience of working in a Life Sciences research products/tools business.

More reasons to join us:

bit.bio provides a vibrant and dynamic work environment in an exciting, fast-moving time for biology. We work with cutting edge technologies and with our world-leading scientific advisory board. We conduct pioneering work with real-world impact.

We trust our people to make significant contributions early on with opportunities to be involved in projects that are key to the success and growth of our young company. We invest in people, creating opportunities for personal development in an inclusive multi-skilled team with ambitious goals that provide opportunities to learn on the job from each other.

Creativity and open minds are encouraged for everyone to contribute to the success of the company.

Please apply via our Careers page at

Closing Date: 03/03/2025