Director, GCP Inspection Readiness and Audits Strategy
About The Position
Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company is led by experienced co-founders who previously led MyoKardia. Kardigan has a cutting-edge discovery platform, a pipeline of late-stage candidates, and a team driven to improve patient lives. The company's values emphasize patient focus, authenticity, curiosity, teamwork, and enabling the impossible. This position is for a seasoned, highly credible Quality professional to lead Kardigan’s approach to inspection readiness and risk-based audit program in the GCP space. The role involves partnering closely with Clinical Quality Assurance and Clinical Quality Leads to develop and execute an annual audit plan and establish organizational readiness for regulatory inspections. The successful candidate will possess credibility, sponsor-side judgment, strategic orchestration skills, strong collaboration abilities, and pragmatic risk-based thinking. This role serves as an extended member of the Clinical Quality Leadership Team.
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.
Nice To Haves
- Experience with medical devices used in clinical trials strongly preferred.
Responsibilities
- 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 ensure inspection readiness is embedded into program and functional execution rather than treated as a separate Quality-owned activity.
- Lead cross-functional alignment on holistic inspection risks, with focus 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
