Director, GCP Inspection Readiness and Audits Strategy
About The Position
Kardigan is seeking a seasoned Quality professional to lead its GCP inspection-readiness strategy and risk-based audit program. The role partners closely with Clinical Quality Assurance and Clinical Quality Leads to develop and execute an annual audit plan and establish and maintain organizational readiness for regulatory inspections. It calls for senior-level credibility, sponsor-side judgment, strategic coordination across functions, strong collaboration, and pragmatic risk-based thinking. The position serves as an extended member of the Clinical Quality Leadership Team. The Director establishes a practical framework for continuous inspection readiness, embeds readiness into program and functional execution, and aligns teams around priority inspection risks. The role develops readiness tools, templates, and training; coordinates mock inspections and coaching; and works with functional leaders to prepare subject matter experts, document owners, inspection support teams, and leadership stakeholders. Readiness includes BIMO expectations covering sponsor, clinical site, and CRO/vendor oversight; IRB and ethics committee interactions; and clinical documentation and data integrity. The Director also helps define inspection-management processes, including response governance and communication flows, and may support inspection readiness for Prolaio. In partnership with Clinical Quality Assurance, the Director develops and maintains a risk-based annual audit plan, monitors regulatory and industry developments, drives audit-plan execution, tracks outcomes and resourcing, and adjusts priorities as risks change. The role maintains a qualified pool of external auditors, provides strategic oversight of audit scope and risk mitigation, and may lead or support audits directly when appropriate. The position is based on site in Princeton, New Jersey, four days per week, Monday through Thursday.
Requirements
- Bachelor’s degree in Life Sciences or a related discipline.
- At least 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.
- 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.
- 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 is strongly preferred.
Responsibilities
- Establish a practical framework for continuous inspection readiness that reflects regulatory expectations and Kardigan’s stage and portfolio.
- Partner with Clinical Quality Leads to embed inspection readiness into program and functional execution.
- Lead cross-functional alignment on holistic inspection risks and identify areas requiring readiness, mitigation, or leadership attention.
- Adapt inspection-readiness strategy as organizational priorities, development programs, and regulatory expectations evolve.
- Define and implement tools, templates, and training for inspection readiness and management.
- Prepare functional leaders, subject matter experts, document owners, inspection support teams, and leadership stakeholders for their roles during inspections.
- Oversee readiness exercises, mock inspections, simulations, and targeted coaching.
- Ensure readiness activities address BIMO inspection expectations, including sponsor, clinical site, and CRO/vendor oversight; IRB and ethics committee interactions; and 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, escalation, and response governance.
- Evaluate and support inspection readiness for Prolaio, if needed.
- 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 regulatory trends, inspection findings, enforcement actions, and industry practices to inform audit strategies.
- Drive execution of the audit plan through planning, coordination, and follow-up.
- Monitor audit progress, outcomes, trends, and resourcing needs, and course-correct with Clinical Quality Assurance when priorities or risks change.
- Establish and maintain a qualified pool of external auditors for audit execution and specialized subject matter needs.
- Provide strategic input and oversight 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
