Senior Manager Clinical Inspection Readiness

Senior Manager Clinical Compliance

The Senior Manager Clinical Compliance leads global inspection readiness and clinical quality initiatives across clinical development programs. This role oversees Trial Master File (TMF) inspection readiness, drives corrective and preventive action (CAPA) and continuous improvement activities, and partners closely with cross-functional teams and external vendors to maintain a robust GCP-compliant quality framework. The position offers the opportunity to spearhead clinical compliance for a growing biotechnology organization, support an exciting pipeline across multiple clinical trial phases, and work directly with executive leadership in a long-term, strategic capacity.

• Lead inspection readiness activities across global clinical development programs, ensuring studies and programs remain in a constant state of readiness for regulatory inspections.
• Develop, implement, and maintain study-level and program-level inspection readiness plans aligned with GCP and regulatory expectations.
• Coordinate cross-functional inspection readiness meetings and governance activities to align stakeholders and track progress.
• Conduct gap assessments and risk evaluations to assess inspection readiness and identify areas requiring remediation.
• Monitor inspection readiness metrics, trends, and key performance indicators, and recommend process and system improvements.
• Promote and embed a culture of continuous inspection readiness across all clinical functions.
• Review sponsor and regulatory audit findings and ensure there is a robust site plan to address observations.
• Facilitate root cause analysis and develop effective CAPAs following audits and inspections.
• Monitor CAPA implementation, verify effectiveness, and ensure timely closure of actions.
• Identify opportunities for continuous process improvement and support Operational Excellence initiatives that strengthen quality systems and inspection readiness.
• Oversee the TMF team to ensure Trial Master Files are inspection-ready at all times.
• Perform TMF health checks and lead or support remediation activities when gaps are identified.
• Monitor TMF quality, completeness, and timeliness to ensure documentation meets regulatory and internal standards.
• Ensure TMF practices comply with the TMF Reference Model and ALCOA+ principles.
• Support implementation of GCP quality initiatives and inspection readiness strategies across clinical development.
• Perform compliance assessments to identify areas of regulatory and quality risk within clinical programs.
• Monitor quality metrics, inspection trends, and compliance indicators to inform risk-based quality management.
• Support internal audits and inspection readiness assessments, partnering with Quality Assurance and other stakeholders.
• Collaborate with CROs and strategic vendors to ensure their processes and deliverables support inspection readiness.
• Review vendor quality metrics and inspection readiness activities, and provide oversight and guidance as needed.
• Support vendor audits and broader vendor oversight programs focused on GCP compliance and quality performance.
• Monitor vendor-related CAPAs and quality improvement initiatives to ensure alignment with sponsor expectations.
• Partner closely with Clinical Operations, Clinical Development, Medical Affairs, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, Medical Writing, Data Management, Biostatistics, Clinical Supply, Information Technology, and Quality Assurance to coordinate inspection readiness activities.
• Provide inspection readiness guidance and best practices across all functional areas, ensuring consistent preparation and execution.
• Develop and deliver inspection readiness training tailored to various functional roles and responsibilities.
• Conduct mock inspections and coach subject matter experts on inspection expectations and effective interview techniques.
• Promote awareness and understanding of GCP regulations and inspection best practices throughout the organization.
• Manage regulatory inspection logistics, including scheduling, timelines, and communication plans.
• Coordinate regulatory document requests and ensure timely, accurate responses during inspections.
• Support inspection war room activities, including daily inspection debrief meetings and issue tracking.
• Prepare functional representatives for regulatory interviews through targeted coaching and mock interviews.
• Assist in developing inspection storyboards and executive briefing materials to ensure consistent and aligned messaging during inspections.
• Manage the TMF group, including direct oversight of at least one team member, providing leadership, coaching, and performance feedback.
• Work closely with executive-level leadership to provide strategic input on clinical compliance and inspection readiness for the organization's pipeline.

• Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline.
• Minimum 8–10 years of experience in Clinical Quality Assurance, GCP Compliance,…