Director, GCP Inspection Readiness and Audits Strategy

The role

This person will lead the approach to inspection readiness and the risk-based audit program in the GCP space. They will partner with Clinical Quality Assurance and Clinical Quality Leads to develop an annual audit plan and maintain organizational readiness for regulatory inspections.

What you will do

• Establish a practical framework for continuous inspection readiness.
• Partner with Clinical Quality Leads to embed inspection readiness into program execution.
• Lead cross-functional alignment on holistic inspection risks.
• Adapt inspection readiness strategy as priorities or regulatory expectations evolve.
• Define and implement tools, templates, and training for inspection readiness and management.
• Partner with functional leaders to ensure stakeholders understand roles before and during inspections.
• Oversee readiness exercises, mock inspections, simulations, and coaching.
• Ensure readiness activities support BIMO inspection expectations.
• Partner with leaders to define the inspection management model.
• Evaluate and support inspection readiness for Prolaio.

Required qualifications

• Bachelor’s degree in Life Sciences or related discipline.
• Minimum of 10 years of relevant experience in clinical trials.
• Direct, senior-level experience supporting or leading inspection readiness activities, particularly in GCP and FDA BIMO contexts.
• Demonstrated experience with clinical development compliance expectations, including sponsor oversight, CRO/vendor oversight, investigator site oversight, IRBs/ethics committees, monitoring, informed
• Excellent communication, facilitation, stakeholder management, influencing, and executive-level briefing skills.
• Demonstrated ability to operate effectively in ambiguity and adjust quickly as organizational priorities evolve.
• Experience in a growing biotechnology company or sponsor organization with evolving processes, roles, and governance.

Nice to have

• Experience with medical devices used in clinical trials

About the company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.