Eblex Group is supporting a growing biotechnology company with an expanding clinical pipeline in the search for a Director Clinical Quality Assurance with GMP exposure.
This is a broad QA role within a lean biotech environment , working closely with Clinical Development and other functions across clinical quality, audits, CAPA, investigations, QMS and inspection readiness.
Key Responsibilities of the Director Clinical Quality Assurance
- Support GCP compliance, quality risk management and inspection readiness
- Manage clinical audit programmes and coordinate internal and external audits
- Review and manage CAPAs, deviations and quality investigations
- Support the company's eQMS , including controlled documents, training and quality events
- Provide QA input into clinical documentation and regulatory activities
- Monitor changes to ICH GCP, MHRA, FDA and EMA requirements
- Support regulatory inspections and audit preparation
- Provide QA input into partnerships, due diligence and licensing activities
What We're Looking For in a Director Clinical Quality Assurance
- 5+ years' experience within biotech or pharma
- 3+ years' experience in GCP Quality Assurance
- Strong understanding of ICH GCP and global clinical trial regulations
- GMP exposure
- Experience with eQMS platforms , ideally Veeva
- Experience supporting MHRA, EMA or FDA inspections
- Strong experience with audits, CAPAs, deviations and investigationsEarly phase or highly regulated therapeutic areas.
- Comfortable working independently within a growing biotech
This is a great opportunity for a hands on QA professional who is looking to take ownership and visibility within a growing clinical development organisation.
Clinical Quality | Good Clinical Practice | Biotech | Quality Assurance | Director Clinical Quality Assurance | GCP | Clinical | Global | Early Phase | Late Phase | Clinical Development
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Director Clinical Quality Assurance in London employer: Eblex Group
Eblex Group offers an exceptional opportunity for the Associate Director, Clinical Operations role within a dynamic and innovative rare disease biotech. With a strong emphasis on collaboration and cross-functional teamwork, employees benefit from a supportive work culture that fosters professional growth and development. Located in a fast-paced environment, this position allows for meaningful contributions to clinical development programmes, making it an attractive choice for those seeking impactful and rewarding employment.
