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GCP Auditing Manager
Manager, GCP Auditing – Join a High-Impact Quality Assurance Team
Are you an experienced GCP Auditor looking to drive quality, compliance, and patient safety across global clinical development programs?
We are seeking a Manager, GCP Auditing to join our high-performing Quality Assurance team, where you will lead and execute risk-based auditing activities across clinical trials, vendors, processes, and partners. This visible role involves collaborating with Clinical Operations, Quality, Regulatory Affairs, and external stakeholders to ensure 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.
- Utilise your expertise in Good Clinical Practice (GCP), FDA and EU regulations, and ICH guidelines to manage complex auditing activities.
- Foster a culture of quality within the organisation.
Hybrid | International/Domestic Travel Required (30–40%)
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Audit scope includes:
- Investigator Site Audits
- Vendor/Service Provider Audits
- Internal Process Audits
- License Partner Audits
- Directed and For-Cause Audits
Key Responsibilities
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Manage the end-to-end audit process including:
- Audit planning and scheduling
- Preparation and execution
- Audit reporting
- CAPA review and follow-up activities
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Conduct internal and external GCP audits globally
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Partner with Clinical Development teams to support risk-based audit strategies for assigned studies
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Interpret and apply FDA, EU, and ICH regulations to identify compliance risks
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Lead or contribute to complex compliance initiatives and cross-functional quality projects
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Support regulatory inspections and inspection readiness activities
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Participate in control room teams during health authority inspections
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Mentor and develop new Quality Assurance team members
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Build strong stakeholder relationships, both internal and external, to promote quality and compliance excellence
What We’re Looking For
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Essential Requirements
✔ Bachelor’s degree in a scientific or related discipline
✔ Minimum 6+ years of experience in pharmaceutical, biotechnology, CRO, or healthcare industry
✔ 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:
- Site audits
- Vendor audits
- Process audits
- 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
🔹 Working within risk-based quality management frameworks
🔹 Mentoring or leadership experience in QA functions
Express interest today: jamie.keith@cpl.com
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