Director, GCP Inspection Readiness & Audits Strategy

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

Job summary

Kardigan, a heart health company in Princeton, NJ, seeks a Director of GCP Inspection Readiness and Audits Strategy to lead the risk-based audit program and readiness for regulatory inspections. On-site 4 days a week, you will partner with Clinical Quality Assurance to ensure sponsor oversight, data integrity, and CRO/vendor coordination.

The role requires 10+ years in clinical trials, senior inspection readiness experience in GCP/FDA environments, and strong communication with regulators and

Qualifications

• Ten years of clinical trial experience.
• Senior-level experience supporting or leading inspection readiness in GCP and FDA BIMO contexts.
• Excellent communication, facilitation, stakeholder management and executive briefing skills.
• Ability to operate effectively in ambiguity and adapt to evolving priorities.
• Experience with medical devices used in clinical trials is preferred.

Responsibilities

• Establish a practical framework for continuous inspection readiness, balancing regulatory expectations with Kardigan’s stage and portfolio.
• Partner with Clinical Quality Leads to embed inspection readiness into programs and functions.
• Lead cross-functional alignment on holistic inspection risks and prioritization.
• Define tools, templates, and training to support readiness and inspection management.
• Oversee readiness exercises, mock inspections, and targeted coaching to build confidence.
• Ensure readiness activities support sponsor oversight, CRO/vendor oversight, and regulatory interactions.
• Define the inspection management model, including front/back room, governance, and communication flows.
• Evaluate readiness for Prolaio as needed.

Skills

GCP inspection

Audit leadership

Regulatory experience

Communication skills

Strategic thinking

Education

Bachelor’s degree in Life Sciences

Job description

Kardigan, a heart health company in Princeton, NJ, seeks a Director of GCP Inspection Readiness and Audits Strategy to lead the risk-based audit program and readiness for regulatory inspections. On-site 4 days a week, you will partner with Clinical Quality Assurance to ensure sponsor oversight, data integrity, and CRO/vendor coordination.

The role requires 10+ years in clinical trials, senior inspection readiness experience in GCP/FDA environments, and strong communication with regulators and