Director, GCP Inspection Readiness and Audits Strategy
- Compensation
- Not disclosed
- Location
- Princeton, New Jersey, United States
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 10+ years
- Category
- Not specified
- Posted
Skills
Must have
- 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.
- Experience with medical devices used in clinical trials strongly preferred.
Full description
About Us
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 Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., 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.
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.
At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—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 eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.
These values are the foundation of our work, empowering us to make a real difference, every day.
Position Title: Director, GCP Inspection Readiness and Audits StrategyDepartment: QualityReports To: Vice President, CMC QualityLocation: Princeton, NJ - On site 4 days a week (Mon to Thurs)Job Summary
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.
The successful candidate will demonstrate:
- Credibility in the space: Brings direct, senior-level experience and can speak fluently with Quality leaders, operational teams, auditors, and regulators.
- Sponsor-side judgment: Understands how expectations apply to a sponsor organization and can translate those expectations into practical readiness activities.