Director Clinical Quality Assurance

Eblex Group; Greater London; On-site; GBP 120,000 - 180,000; Full time

Job summary

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 broad QA role sits within a lean biotech environment and works closely with Clinical Development and other functions across clinical quality, audits, CAPA, investigations, QMS and inspection readiness.

As Director, you will lead GCP compliance, manage audit programmes, drive CAPAs and investigations, and provide QA input

Qualifications

• 5+ years in biotech or pharma QA
• 3+ years in GCP QA
• Strong knowledge of ICH GCP and global regulations
• GMP exposure
• Experience with eQMS platforms (Veeva)
• Experience supporting MHRA, EMA or FDA inspections
• Audits, CAPAs, deviations and investigations experience
• Hands-on QA professional who can work independently

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 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

Skills

GCP QA

Audits

CAPA & Deviations

Regulatory Inspections

eQMS (Veeva)

Tools

Veeva eQMS

GxP Systems

Job description

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