Director GCP/GVP Inspection Readiness and Management

 

Title: Director, GCP/GVP Inspection Readiness and Management

Position Overview

Provide strategic leadership for Vor's global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs by overseeing inspection readiness, regulatory inspection management, and internal quality audits. Lead the Inspection Readiness and Management Program, serving as the primary Inspection Lead responsible for planning, hosting, facilitating, and directing regulatory inspections conducted by the FDA (BIMO), MHRA, PMDA, EMA, and other global Health Authorities. Lead and execute a risk-based internal GCP/GVP audit program to evaluate compliance with applicable regulations, industry standards, and company procedures.

Partner with leadership and cross-functional stakeholders to maintain a continuous state of inspection readiness, ensure effective execution of regulatory inspections and audits, foster high-quality regulatory interactions, and drive timely responses to inspection and audit observations, CAPAs, and continuous improvement initiatives. Provide strategic leadership across Clinical Operations, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biometrics, Data Management, Quality, and external partners to promote sustainable compliance, operational excellence, and inspection success throughout the product development lifecycle

Responsibilities

· Lead the development, implementation, and continuous improvement of the global GCP/GVP Inspection Readiness Program, ensuring a sustained state of inspection readiness across the organization and its external partners.

· Serve as the primary Inspection Lead and Host for FDA BIMO, MHRA, PMDA, EMA, and other Health Authority inspections

· Provide leadership and oversight for inspection readiness activities across clinical development, pharmacovigilance, regulatory affairs, data management, biometrics, medical affairs, and quality functions.

· Establish and maintain inspection readiness strategies for CROs, investigator sites, pharmacovigilance vendors, laboratories, alliance partners, and other outsourced service providers.

· Partner with internal and external stakeholders to identify compliance risks, develop mitigation strategies, and drive sustainable improvements that support successful inspection outcomes.

· Provide guidance on global GCP and GVP regulatory requirements, emerging inspection trends, and Health Authority expectations throughout the product development lifecycle.

· Lead inspection readiness assessments, mock inspections, and other proactive activities to evaluate organizational preparedness and identify opportunities for improvement.

· Lead cross-functional development of responses to observations and findings, CAPAs, effectiveness checks, and regulatory commitments.

· Lead the development and communication of inspection readiness dashboards, KPIs, risk metrics, and trend analyses to Quality and Leadership.

· Develop, implement, and lead a risk-based GCP and Pharmacovigilance (GVP) internal audit program, including planning, conducting, reporting, and overseeing corrective and preventive actions (CAPAs) to assess compliance, identify risks, and drive continuous quality improvement.

Requirements

· Bachelor's degree in life sciences, pharmacy, chemistry, or related field.

· Minimum of twelve (12) years of experience in the regulated pharmaceutical and/or biotechnology industry, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility.

· Deep understanding of global regulatory requirements and industry standards, including GCP, GVP, ICH guidelines, 21 CFR Part 11, ALCOA+ principles and inspection readiness expectations.

· Demonstrated experience supporting multiple health authority inspections across different health authorities (e.g., FDA, PMDA, MHRA, EMA, etc..) including inspection preparation, response coordination, remediation activities, and functional representation during regulatory inspections.

· Excellent interpersonal, oral, and written communication skills with proven ability to build strong collaborative relationships and influence alignment across key internal and external stakeholders.

· Demonstrated ability to effectively lead and prioritize within a fast-paced, evolving, and highly regulated environment.

· Business travel, including international, approx. 25-50%

The salary range for this Director, GCP/GVP Inspection Readiness and Management position is expected to be between $220,000 and $230,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.