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<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}"> </span></p>
<div data-olk-copy-source="MessageBody">Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.<br><br></div>
<div>It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.</div>
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<div>Led by Tassos Gianakakos, Jay Edelberg, <span data-olk-copy-source="MessageBody">M.D., Ph.D.,</span> and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.</div>
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<div>We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.</div>
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<div>At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. <strong>Driven by patients and their families</strong>, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in <strong>being authentic</strong>—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an <strong>eagerness to learn</strong>, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to <strong>winning as a team</strong> with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to <strong>enable the impossible</strong> because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.</div>
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<div>These values are the foundation of our work, empowering us to make a real difference, every day.</div>
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<div> </div></div><p><strong>Position Title: Director, GCP Inspection Readiness and Audits Strategy</strong></p>
<p><strong>Department: Quality</strong></p>
<p><strong>Reports To: Vice President, CMC Quality</strong></p>
<p><strong>Location: Princeton, NJ - On site 4 days a week (Mon to Thurs)</strong></p>
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<p><strong>Job Summary</strong></p>
<p>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.</p>
<p>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.</p>
<p>The successful candidate will demonstrate:</p>
<ul>
<li><strong>Credibility in the space:</strong> Brings direct, senior-level experience and can speak fluently with Quality leaders, operational teams, auditors, and regulators.</li>
<li><strong>Sponsor-side judgment:</strong> Understands how expectations apply to a sponsor organization and can translate those expectations into practical readiness activities.</li>
<li><strong>Strategic orchestration:</strong> Aligns people, priorities, risks, and timelines across functions without creating unnecessary bureaucracy.</li>
<li><strong>Strong collaboration:</strong> Partners effectively with CQA and other GxP functions.</li>
<li><strong>Pragmatic risk-based thinking:</strong> Focuses attention and resources on the areas that matter most.</li>
</ul>
<p>This role serves as an extended member of the Clinical Quality Leadership Team.</p>
<p> </p>
<p><strong>Essential Duties and Responsibilities</strong></p>
<p><em>Inspection Readiness and Management</em></p>
<ul>
<li>Establish a practical framework for what it means to be “continuously inspection ready,” balancing regulatory expectations with Kardigan’s stage and evolving portfolio.</li>
<li>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.</li>
<li>Lead cross-functional alignment on holistic inspection risks, with focus on the highest-priority areas requiring proactive readiness, mitigation, or leadership attention.</li>
<li>Adapt inspection readiness strategy as organizational priorities, development programs, or regulatory expectations evolve.</li>
<li>Define and implement the tools, templates, and training needed to support inspection readiness and inspection management.</li>
<li>Partner with functional leaders to ensure subject matter experts, document owners, inspection support teams, and leadership stakeholders understand their roles before and during inspections.</li>
<li>Oversee readiness exercises, mock inspections, inspection simulations, and targeted coaching to build organizational confidence and consistency.</li>
<li>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.</li>
<li>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.</li>
<li>Evaluate and support, if needed, inspection readiness for Prolaio.</li>
</ul>
<p><em>Audit Strategy & Execution Oversight</em></p>
<ul>
<li>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.</li>
<li>Monitor relevant regulatory trends, inspection findings, enforcement actions, and industry practices to inform Kardigan’s audit strategies.</li>
<li>Drive execution of the aligned audit plan through effective planning, coordination, and follow-up.</li>
<li>Monitor audit progress, outcomes, trends, and resourcing needs, and course-correct in partnership with Clinical Quality Assurance when priorities or risks change.</li>
<li>Establish and maintain a qualified pool of external auditors to support audit execution and specialized subject matter needs.</li>
<li>Provide oversight and strategic input on audit scope, prioritization, issue escalation, and audit-related risk mitigation.</li>
<li>Lead or support audits directly when appropriate, based on business need, expertise, and availability.</li>
</ul>
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<p><strong>Qualifications and Skills</strong></p>
<ul>
<li>Bachelor’s degree in Life Sciences or related discipline.</li>
<li>Minimum of 10 years of relevant experience in clinical trials.</li>
<li>Direct, senior-level experience supporting or leading inspection readiness activities, particularly in GCP and FDA BIMO contexts.</li>
<li>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.</li>
<li>Excellent communication, facilitation, stakeholder management, influencing, and executive-level briefing skills.</li>
<li>Demonstrated ability to operate effectively in ambiguity and adjust quickly as organizational priorities evolve.</li>
<li>Experience in a growing biotechnology company or sponsor organization with evolving processes, roles, and governance.</li>
<li>Experience with medical devices used in clinical trials strongly preferred.</li>
</ul>
<p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>Exact Compensation may vary based on skills, experience and location.</p></div><div class="title">Pay range</div><div class="pay-range"><span>$194,000</span><span class="divider">—</span><span>$250,000 USD</span></div></div></div>