Director, GCP Inspection Readiness and Audits Strategy

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. Led by co-founders with a track record of success—including the discovery and development of mavacamten, the first cardiac myosin inhibitor, which led to an acquisition by Bristol Myers Squibb in 2020—Kardigan combines a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team driven to improve patients' lives.

At Kardigan, our values guide how we work, interact, and achieve our goals: patient-centricity, authenticity, curiosity, teamwork, and a commitment to enabling the impossible. We foster an environment where every person is fully accepted, risks are taken to unlock innovation, and excellence is pursued with urgency and intention.

Location: Princeton, NJ (Preferred) or South San Francisco, CA – On site 4 days a week (Mon to Thurs)

About the role

We are seeking a seasoned, highly credible Quality professional to lead Kardigan’s approach to inspection readiness and risk-based audit program in the GCP space. This role will partner closely with Clinical Quality Assurance and Clinical Quality Leads to develop and execute an annual audit plan and establish & maintain organizational readiness for regulatory inspections.

Responsibilities

• Inspection Readiness and Management
  • Establish a practical framework for what it means to be “continuously inspection ready,” balancing regulatory expectations with Kardigan’s stage and evolving portfolio.
  • Partner closely with Clinical Quality Leads to embed inspection readiness into program and functional execution rather than treating it as a separate Quality-owned activity.
  • Lead cross-functional alignment on holistic inspection risks, focusing on the highest-priority areas requiring proactive readiness, mitigation, or leadership attention.
  • Adapt inspection readiness strategy as organizational priorities, development programs, or regulatory expectations evolve.
  • Define and implement the tools, templates, and training needed to support inspection readiness and inspection management.
  • Partner with functional leaders to ensure subject matter experts, document owners, inspection support teams, and leadership stakeholders understand their roles before and during inspections.
  • Oversee readiness exercises, mock inspections, inspection simulations, and targeted coaching to build organizational confidence and consistency.
  • Ensure readiness activities support BIMO inspection expectations, including sponsor oversight, clinical site oversight, CRO/vendor oversight, IRB/ethics committee interactions, clinical documentation, and data integrity.
  • Partner with Quality and functional leaders to define the inspection management model, including front room, back room, strategy room, documentation support, communication flow, escalation, and response governance.
  • Evaluate and support, if needed, inspection readiness for Prolaio.
• Audit Strategy & Execution Oversight
  • Partner with Clinical Quality Assurance to develop and maintain a risk-based annual audit plan aligned with program priorities, regulatory expectations, and emerging inspection risks.
  • Monitor relevant regulatory trends, inspection findings, enforcement actions, and industry practices to inform Kardigan’s audit strategies.
  • Drive execution of the aligned audit plan through effective planning, coordination, and follow-up.
  • Monitor audit progress, outcomes, trends, and resourcing needs, and course-correct in partnership with Clinical Quality Assurance when priorities or risks change.
  • Establish and maintain a qualified pool of external auditors to support audit execution and specialized subject matter needs.
  • Provide oversight and strategic input on audit scope, prioritization, issue escalation, and audit-related risk mitigation.
  • Lead or support audits directly when appropriate, based on business need, expertise, and availability.

Requirements

• 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 consent, protocol deviations, safety reporting, documentation quality, and data integrity.
• 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.
• Experience with medical devices used in clinical trials strongly preferred.

Pay

Exact compensation may vary based on skills, experience, and location. Pay range: $194,000 - $250,000 USD.

Schedule

On site 4 days a week (Monday to Thursday).