Clinical Quality Assurance Director

Clinical Quality Assurance Director – 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

• Innovative biotech moving into pivotal trials for promising drug targeting specific cancers

• 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

• Establish and embed robust quality management procedures

• Develop and implement GCP quality systems aligned with relevant standards (ICH, FDA, EMA).

• Provide QA oversight, coordinate and implement audit plans for CROs & GCP vendors

• Ensure inspection readiness and host GCP inspections (FDA, EMA, MHRA).

• Drive continuous improvement in quality systems and compliance strategies.

You

• Degree in Biological 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 GCP regulations and clinical development.

• Experience working with CROs.

• Experience leading/hosting US and international health authority inspections.

• Ability to thrive in a fast-paced, collaborative environment.