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 SummaryWe 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.
- Strategic orchestration: Aligns people, priorities, risks, and timelines across functions without creating unnecessary bureaucracy.
- Strong collaboration: Partners effectively with CQA and other GxP functions.
- Pragmatic risk-based thinking: Focuses attention and resources on the areas that matter most.
This role serves as an extended member of the Clinical Quality Leadership Team.
Essential Duties and ResponsibilitiesInspection 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 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.
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.
Qualifications and Skills- 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.
Exact Compensation may vary based on skills, experience and location.
Pay range
$194,000-$250,000 USD
