Quality Assurance Director (GMP)

Direct message the job poster from Carrot Recruitment

Senior Consultant - Regulatory Affairs & QA - UK & US

Quality Assurance Director (GMP) – Innovative and fast-growing biotech – Cambridgeshire or Cheshire with hybrid working (open to other UK locations) - £excellent basic salary, 20-30% bonus, pension, healthcare, life assurance, death in service, 25 days holiday + BH

The Company

• Fast-growing and ambitious yet realistic with future growth plans

• Very flexible, agile organisation

• Family friendly company who genuinely value employee well-being

The Role

• Develop and implement GMP quality systems aligned with relevant standards (ICH, FDA, EMA).
• Provide QA oversight for GMP service providers and key stakeholders.
• Review GXP documents related to method development, validation, and manufacturing.
• Review regulatory CMC documentation (IMPD/IND/NDA).
• Conduct and oversee audits of CROs, CDMOs, and GMP vendors.
• Ensure inspection readiness and host GMP inspections, managing follow-ups and CAPAs.
• Oversee GMP product batch record review and disposition.
• Drive continuous improvement in quality systems and compliance strategies.

You

• Degree in Chemistry, Life Sciences, or a related field (advanced degree preferred).
• Experienced in a senior, hands-on Quality role within the pharmaceutical or biotech industry.
• Strong expertise in GMP regulations and late-stage clinical/commercial development.
• Experience managing CMOs/CDMOs for drug substance (DS) and drug product (DP).
• Proven track record in auditing GMP facilities.
• Ability to thrive in a fast-paced, collaborative environment.

What should you do next?

This GMP Quality Director role is one not to be missed; This is your chance to be part of an innovative team making a tangible difference in the lives of cancer patients. If you're ready for your next challenge in Quality Assurance, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we'll be more than happy to assist.

Seniority level

• Director

Employment type

• Full-time

Job function

• Quality Assurance