The Global Quality Auditor GCP is responsible for ensuring compliance with Good Clinical Practice (GCP) across global clinical activities. The role includes planning and executing risk-based GCP audits of investigator sites, CROs, vendors, laboratories, and internal systems, as well as supporting regulatory inspections and managing CAPAs. The position contributes to global audit programs, provides GCP compliance guidance, and supports continuous quality improvement across clinical development operations.
Non-Negotiable Skills, Qualifications, and Experience:
- Bachelor’s or Master’s degree in a scientific discipline
- Minimum 7 years of GCP auditing experience
- Experience performing investigator site audits
- Experience performing vendor audits
- Experience performing internal process or system audits
- Demonstrated knowledge of ICH-GCP guidelines
- Demonstrated knowledge of domestic and international GCP regulations
- Experience managing audit findings and CAPAs
- Experience supporting regulatory inspections
- Fluency in English (written and spoken)
- Experience using electronic quality or audit management systems in a regulated environment
- Willingness and ability to travel internationally (approximately 30%)
Desirable Skills, Qualifications, and Experience
- 10+ years of GCP auditing experience
- Experience auditing central laboratories
- Experience conducting due diligence audits for acquisitions
- Experience auditing potential vendors prior to qualification
- Experience with joint GXP audits (e.g., GLP, GPV, IVD/MD/Technology)
- Experience contributing to risk-based audit program development
- Experience leading quality improvement initiatives
- Familiarity with statistical principles and data analysis
- Experience developing policies, standards, or training materials within a quality function
- Experience working within global biopharmaceutical clinical development environments
What the Assignment Offers:
- Global GCP Auditor role within an established biopharmaceutical organization
- Direct responsibility for investigator site, CRO, vendor, and internal system audits
- Involvement in regulatory inspection support and CAPA oversight
- Exposure to international clinical development programs and global GCP compliance frameworks
- Opportunity to contribute to risk-based audit strategy and quality improvement initiatives
- Hybrid working model (approx. 40% on-site) with international travel (~30%)
- High-impact position ensuring clinical data integrity and regulatory compliance
Interested in discussing this opportunity confidentially?
Maurits van Sloun
? m.vansloun@panda-int.com
? +32 460 25 75 29
The Global Quality Auditor GCP is responsible for ensuring compliance with Good Clinical Practice (GCP) across global clinical activities. The role includes planning and executing risk-based GCP audits of investigator sites, CROs, vendors, laboratories, and internal systems, as well as supporting regulatory inspections and managing CAPAs. The position contributes to global audit programs, provides GCP compliance guidance, and supports continuous quality improvement across clinical development operations.
Non-Negotiable Skills, Qualifications, and Experience:
- Bachelor’s or Master’s degree in a scientific discipline
- Minimum 7 years of GCP auditing experience
- Experience performing investigator site audits
- Experience performing vendor audits
- Experience performing internal process or system audits
- Demonstrated knowledge of ICH-GCP guidelines
- Demonstrated knowledge of domestic and international GCP regulations
- Experience managing audit findings and CAPAs
- Experience supporting regulatory inspections
- Fluency in English (written and spoken)
- Experience using electronic quality or audit management systems in a regulated environment
- Willingness and ability to travel internationally (approximately 30%)
Desirable Skills, Qualifications, and Experience
- 10+ years of GCP auditing experience
- Experience auditing central laboratories
- Experience conducting due diligence audits for acquisitions
- Experience auditing potential vendors prior to qualification
- Experience with joint GXP audits (e.g., GLP, GPV, IVD/MD/Technology)
- Experience contributing to risk-based audit program development
- Experience leading quality improvement initiatives
- Familiarity with statistical principles and data analysis
- Experience developing policies, standards, or training materials within a quality function
- Experience working within global biopharmaceutical clinical development environments
What the Assignment Offers:
- Global GCP Auditor role within an established biopharmaceutical organization
- Direct responsibility for investigator site, CRO, vendor, and internal system audits
- Involvement in regulatory inspection support and CAPA oversight
- Exposure to international clinical development programs and global GCP compliance frameworks
- Opportunity to contribute to risk-based audit strategy and quality improvement initiatives
- Hybrid working model (approx. 40% on-site) with international travel (~30%)
- High-impact position ensuring clinical data integrity and regulatory compliance
Interested in discussing this opportunity confidentially?
Maurits van Sloun
? m.vansloun@panda-int.com
? +32 460 25 75 29