GCP Auditing Manager
Posted Today by Cpl Life Sciences
Negotiable
Undetermined
Hybrid
London Area, United Kingdom
Summary: The GCP Auditing Manager will play a crucial role in ensuring quality and compliance in global clinical development programs by leading risk-based auditing activities. This position requires collaboration with various stakeholders to drive inspection readiness and maintain continuous compliance. The role involves managing complex audits and fostering a culture of quality within the organization. The position is hybrid with international and domestic travel required (30–40%).
Key Responsibilities:
- Manage the end-to-end audit process, including audit planning and scheduling, preparation and execution, audit reporting, and CAPA review and follow-up activities.
- Conduct internal and external GCP audits globally.
- Partner with Clinical Development teams to support risk-based audit strategies for assigned studies.
- Interpret and apply FDA, EU, and ICH regulations to identify and assess compliance risks.
- Lead or contribute to complex compliance initiatives and cross-functional quality projects.
- Support regulatory inspections and inspection readiness activities.
- Participate as a member of inspection and control room teams during health authority inspections.
- Mentor, coach, and support the development of new Quality Assurance team members.
- Build strong relationships with internal stakeholders and external partners to promote quality and compliance excellence.
Key Skills:
- Bachelor's degree in a scientific or related discipline.
- Minimum 6+ years of pharmaceutical, biotechnology, CRO, or healthcare industry experience.
- Minimum 4+ years of direct GCP auditing experience.
- Strong working knowledge of ICH-GCP Guidelines, FDA Regulations, EU Clinical Trial Regulations, and Global GCP compliance requirements.
- Experience conducting multiple GCP audit types including site, vendor, and process audits.
- Experience managing audit findings, CAPAs, and compliance investigations.
- Excellent written and verbal communication skills.
- Ability to influence and collaborate with stakeholders at all levels.
- Strong organisational skills and ability to manage multiple priorities independently.
Salary (Rate): undetermined
City: London Area
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Are you an experienced GCP Auditor looking to play a critical role in ensuring quality, compliance, and patient safety across global clinical development programs? We are seeking a Manager, GCP Auditing to join a high-performing Quality Assurance team, where you will lead and execute risk-based auditing activities across clinical trials, vendors, processes, and partners. This is an opportunity to work in a highly visible role, partnering with stakeholders across Clinical Operations, Quality, Regulatory Affairs, and external partners to drive inspection readiness and continuous compliance.
About the Role
As a Manager, GCP Auditing, you will build strategic partnerships and implement risk-based quality auditing activities across global clinical development programs. Leveraging your expertise in Good Clinical Practice (GCP), FDA and EU regulations, and ICH guidelines, you will independently manage complex auditing activities and support a culture of quality throughout the organisation.
Hybrid | International/Domestic Travel Required (30–40%)
You will conduct a variety of audit types including:
- Investigator Site Audits
- Vendor/Service Provider Audits
- Internal Process Audits
- License Partner Audits
- Directed and For-Cause Audits
Key Responsibilities
Manage the end-to-end audit process, including:
- Audit planning and scheduling
- Preparation and execution
- Audit reporting
- CAPA review and follow-up activities
Conduct internal and external GCP audits globally
Partner with Clinical Development teams to support risk-based audit strategies for assigned studies
Interpret and apply FDA, EU and ICH regulations to identify and assess compliance risks
Lead or contribute to complex compliance initiatives and cross-functional quality projects
Support regulatory inspections and inspection readiness activities
Participate as a member of inspection and control room teams during health authority inspections
Mentor, coach and support the development of new Quality Assurance team members
Build strong relationships with internal stakeholders and external partners to promote quality and compliance excellence
What We're Looking For
Essential Requirements
- Bachelor's degree in a scientific or related discipline
- Minimum 6+ years of pharmaceutical, biotechnology, CRO or healthcare industry experience
- Minimum 4+ years of direct GCP auditing experience
- Strong working knowledge of:
- ICH-GCP Guidelines
- FDA Regulations
- EU Clinical Trial Regulations
- Global GCP compliance requirements
- Experience conducting multiple GCP audit types including site, vendor and process audits
- Experience managing audit findings, CAPAs and compliance investigations
- Excellent written and verbal communication skills
- Ability to influence and collaborate with stakeholders at all levels
- Strong organisational skills and ability to manage multiple priorities independently
Preferred Experience
- Regulatory inspection support experience
- Global clinical development experience
- Experience working within risk-based quality management frameworks
- Previous mentoring or leadership experience within QA functions
If you feel you're a match for this role, get in touch - jamie.keith@cpl.com