- Clinical QA Consultant – External Service Provider Quality Assurance (ESPQA)
- Location: West London, UK – Hybrid (2/3 days per week on site)
- 18 Month Contract, Inside IR35
- Up to £30.50 per hour PAYE
Please note: Relocation support is not available for this role. Applicants must already have the right to work in the country they are applying to and be able to access the stated location.
About the Role
CPL Life Sciences is partnering with a Top 3 global pharmaceutical company to recruit a Clinical QA Consultant, External Service Provider Quality Assurance (ESPQA). This is a senior Quality role within R&D, responsible for end-to-end quality oversight of external service providers (ESPs) supporting global clinical trials and QA activities. The role plays a critical part in ensuring external partners operate in full compliance with regulatory and internal quality standards across Development (Clinical, PV, GLP). You will work closely with global and regional stakeholders to proactively manage risk, performance, inspection readiness, and continuous improvement across the external vendor landscape.
Key Responsibilities:
External Service Provider Oversight
- Review and approve qualification of external service providers supporting:
- Global clinical trials
- Maintain ongoing quality oversight throughout the ESP lifecycle
Quality Agreements
- Lead the negotiation and execution of Quality Assurance Agreements (QAAs) and quality terms with external service providers
- Ensure contractual alignment with regulatory and internal quality requirements
Risk-Based Quality Management
- Review and approve Quality Risk Assessments (QRAs) for ESPs
- Proactively identify and evaluate:
- Quality risks
- Performance trends
- Key quality metrics
- Support mitigation planning and timely communication of risks to stakeholders
Issue Management & Escalation
- Review and approve quality issues related to ESPs
- Ensure appropriate escalation of major and critical issues
- Support serious breach assessment and regulatory reporting where required
Cross-Functional Collaboration
- Work closely with internal stakeholders including:
- Global Medical Affairs
- Vendor Partnership & Governance
- Study Start-Up teams
- Country/Regional Quality
- Procurement
- Ensure alignment on risk evaluation, communication, and follow-up actions
Quality Metrics & Reporting
- Review and challenge quality metrics and ESP performance indicators
- Ensure follow-up actions are implemented and escalated when necessary
Inspection Readiness & Audits
- Ensure inspection readiness for ESP-related activities
- Support:
- Internal and external audits
- Health Authority inspections related to external provider management
Compliance & Continuous Improvement
- Ensure compliance with GCP, GLP, GVP, and GMP regulations
- Drive continuous improvement of quality processes related to external service provider oversight
Role Requirements:
Experience
- 12+ years’ experience within pharmaceutical development
- Strong background in:
- Quality Management Systems
- Vendor / CRO management
- Demonstrated experience in regulated environments and inspection readiness
Education
- Bachelor’s degree
Skills & Expertise
- Strong working knowledge of GCP (essential), with good understanding of GLP, GVP and GMP
- Proven experience managing external service providers and applying quality oversight models
- Expertise in risk-based quality management, quality metrics and KPI monitoring
- Strong root cause analysis, critical thinking, and problem-solving skills
- Effective stakeholder engagement across international and cross-functional teams
- Experience with:
- Medical Affairs activities
- Non-interventional studies (NIS)
- PASS and Real-World Evidence (RWE) is highly desirable
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