Director Clinical Quality Assurance

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.

• 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

• 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
  
  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.

Clinical Quality | Good Clinical Practice | Biotech | Quality Assurance | Director Clinical Quality Assurance | GCP | Clinical | Global | Early Phase | Late Phase | Clinical Development