At a Glance
- Tasks: Lead quality assurance in a dynamic biotech environment, ensuring compliance and readiness for inspections.
- Company: Join a growing biotechnology company with an expanding clinical pipeline.
- Benefits: Competitive salary, opportunities for growth, and a chance to make a real impact.
- Other info: Work independently in a supportive, innovative team focused on quality and compliance.
- Why this job: Take ownership in a hands-on role and shape the future of clinical development.
- Qualifications: 5+ years in biotech/pharma and strong GCP Quality Assurance experience required.
The predicted salary is between 60750 - 74250 £ per year.
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:
- 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:
- 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 investigations in early 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.
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.
