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The Director, Inspection Readiness is a senior, handson leader responsible for ensuring continuous inspection readiness across all clinical trials throughout their lifecycle. This role provides strategic direction, operational execution, and expert mentorship to study teams and Trial Master File (TMF) Owners, ensuring TMF quality, regulatory compliance, and inspection defensibility at all times. This is a player-coach role. In addition to setting strategy and mentoring TMF Owners, the Director is expected to actively support TMF activities as needed-including direct document review, classification, and filing-particularly during periods of heightened inspection risk, limited resourcing, or active inspection preparation.
Key Responsibilities
Inspection Readiness Leadership
- Own and continuously evolve the inspection readiness strategy for Clinical Research and Data Sciences, ensuring trials are inspectionready from startup through closeout.
- Serve as the organizational subject matter expert for regulatory inspections (e.g., FDA BIMO, PAI, other Health Authority inspections), advising teams and leadership on inspection expectations, risks, and mitigation strategies.
- Act as a primary readiness lead during inspections, supporting frontroom and backroom activities, inspection logistics, and realtime issue escalation and resolution.
- Assess and address inspection readiness requirements outside of FDA (e.g., exUS or partnerdriven inspections), as applicable.
- Oversee planning, execution, and follow-up of internal reviews/audits, including identifying risks, developing corrective and preventive action (CAPA) plans, and verifying implementation.
Trial Master File (TMF) Oversight
- Provide enterpriselevel oversight of TMF quality, completeness, and compliance with ICH GCP, applicable regulations, and internal SOPs across all clinical programs.
- Ensure TMF inspection readiness through planned quality assessments, including interim, precloseout, preaudit, and preinspection reviews of TMF and Investigator Site File documentation.
- Drive alignment between TMF content, clinical conduct, and inspection narratives, including CSR appendices, BIMO narratives, and traceability expectations.
- Partner with Clinical Operations, Data Management, Regulatory, QA, Biometrics, and other functions to ensure TMF documentation accurately reflects trial execution and decisionmaking.
Mentorship & Development of TMF Owners
- Build and sustain a TMF Owner capability model across the clinical portfolio, ensuring consistent, inspectionready ownership regardless of trial phase, vendor model, or geography.
- Act as a mentor and coach to individuals serving as TMF Owners, reinforcing their accountability for TMF filing, completeness, and quality.
- Establish clear expectations, role definitions, and success criteria for TMF Owners, including ownership of document quality, timeliness, and inspection defensibility.
- Provide handson guidance to TMF Owners on:
- Interpreting regulatory inspection expectations related to the TMF
- Identifying inspectioncritical documents and highrisk areas
- Preparing defensible TMF narratives and responses to inspector questions
- Develop and deliver targeted training and coaching to strengthen inspection readiness behaviors, TMF governance practices, and inspection interview preparedness.
- Serve as an escalation point and trusted advisor when complex TMF quality issues, CRO performance concerns, or inspection risks arise.
HandsOn TMF Support (Player-Coach Model)
- Step in as a direct contributor to TMF activities as needed, including document review, classification, and filing, to ensure inspection readiness is maintained.
- Provide tactical TMF support during periods of increased inspection risk, resource constraints, or identified quality gaps.
- Model inspectionready TMF practices through direct execution, reinforcing expectations through action as well as guidance.
- Support TMF Owners by addressing urgent gaps or backlogs that could pose inspection risk, while maintaining clear accountability for TMF ownership.
Site & Audit Readiness
- Lead sitelevel inspection and audit preparedness activities, including coordination with clinical sites, CROs, and internal stakeholders.
- Oversee planning, execution, and followup of site audits and mock inspections, including risk identification, CAPA development, and verification of implementation.
- Support site and study teams in mock interviews, document readiness, and inspection behavior expectations.
Governance, Metrics & Continuous Improvement
- Establish and monitor TMF and inspection readiness metrics and dashboards to drive transparency, accountability, and proactive risk management.
- Translate inspection readiness data into clear executivelevel risk narratives and decision points for senior leadership.
- Identify systemic TMF and inspection readiness gaps and lead continuous improvement initiatives, including updates to SOPs, work instructions, and training materials.
- Review and provide input on SOPs and work instructions impacting clinical trial conduct and inspection readiness.
Qualifications
Education
- Bachelor's degree required, or equivalent combination of education, training, and experience.
- Minimum of 10 years of pharmaceutical or biotechnology experience in a GCPregulated environment.
- Minimum of 5 years of handson experience with TMF/records management and essential clinical trial documentation.
- Demonstrated experience leading or supporting regulatory inspections, including FDA BIMO inspections and site audits.
- Experience developing and executing inspection readiness strategies across multiple clinical programs.
- Strong regulatory knowledge, including ICH GCP and FDA inspection processes.
- Demonstrated ability to operate as both a strategic leader and handson contributor.
- Strong interpersonal skills with the ability to influence, mentor, and challenge stakeholders at all levels.
- Sound judgment and calm decisionmaking in highrisk or inspectiondriven scenarios.
- Continuousimprovement mindset with the ability to work independently in a fastmoving, resourceconstrained environment.
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US WorldMeds
Mar 10, 2026