Director, GCP Inspection Readiness & Audits Strategy

Kardigan; Princeton (NJ); On-site; USD 194,000 - 250,000; Full time

Job summary

Kardigan is seeking a seasoned Quality leader to direct GCP inspection readiness and audits strategy from its Princeton, NJ site. You will partner with Clinical Quality Assurance to create and execute an annual audit plan and ensure readiness for regulatory inspections across the organization.

The role requires senior-level expertise in GCP/BIMO contexts, strong cross-functional collaboration, and a proactive approach to risk-based planning.

Qualifications

• Bachelor’s degree in Life Sciences or related discipline.
• 10+ years of clinical trials experience.
• Senior-level experience in inspection readiness (GCP/FDA BIMO).
• Experience with sponsor/CRO/vendor oversight, IRBs and data integrity.
• Excellent communication and stakeholder management.

Responsibilities

• Lead inspection readiness and risk-based audit programs.
• Develop and maintain a risk-based annual audit plan.
• Coordinate cross-functional readiness and staff training.
• Oversee audits and engage external auditors as needed.
• Ensure compliance with regulatory expectations and data integrity.

Skills

Communication

Facilitation

Stakeholder management

Executive briefing

Leadership

Regulatory knowledge

Education

Bachelor's degree in Life Sciences or related discipline

Job description

Kardigan is seeking a seasoned Quality leader to direct GCP inspection readiness and audits strategy from its Princeton, NJ site. You will partner with Clinical Quality Assurance to create and execute an annual audit plan and ensure readiness for regulatory inspections across the organization.

The role requires senior-level expertise in GCP/BIMO contexts, strong cross-functional collaboration, and a proactive approach to risk-based planning.