Clinical QA Consultant
Posted 2 days ago by Cpl Life Sciences
£31 Per hour
Inside
Hybrid
Hammersmith, England, United Kingdom
Summary: The Clinical QA Consultant role focuses on overseeing the quality assurance of external service providers (ESPs) in support of global clinical trials for a leading pharmaceutical company. This senior position requires extensive experience in quality management and regulatory compliance, ensuring that ESPs adhere to internal and external quality standards. The consultant will collaborate with various stakeholders to manage risks, performance, and continuous improvement initiatives. The role is hybrid, requiring on-site presence in West London for part of the week.
Key Responsibilities:
- External Service Provider Oversight
- Quality Agreements
- Risk-Based Quality Management
- Issue Management & Escalation
- Cross-Functional Collaboration
- Quality Metrics & Reporting
- Inspection Readiness & Audits
- Compliance & Continuous Improvement
Key Skills:
- 12+ years’ experience within pharmaceutical development
- Strong background in Quality Management Systems and Vendor/CRO management
- Demonstrated experience in regulated environments and inspection readiness
- Bachelor’s degree
- Strong working knowledge of GCP, with understanding of GLP, GVP, and GMP
- Proven experience managing external service providers
- Expertise in risk-based quality management and quality metrics
- 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, PASS, and Real-World Evidence is highly desirable
Salary (Rate): £30.50 hourly
City: Hammersmith
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: inside IR35
Seniority Level: Senior
Industry: Other
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