SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Salary: USD 220,000 - 230,000 / annual
Vor Bio is seeking a Director of GCP/GVP Inspection Readiness and Management to provide strategic leadership for the company's global Clinical and Pharmacovigilance Quality Assurance programs. This role is responsible for overseeing inspection readiness, regulatory inspection management, and internal quality audits across the organization.
You will lead Vor's Inspection Readiness and Management Program, serving as the primary Inspection Lead for regulatory inspections conducted by the FDA (BIMO), MHRA, PMDA, EMA, and other global Health Authorities. You will plan, host, facilitate, and direct these inspections while leading a risk-based internal GCP/GVP audit program to evaluate compliance with applicable regulations, industry standards, and company procedures.
Key responsibilities include:
- Developing, implementing, and continuously improving the global GCP/GVP Inspection Readiness Program to maintain a sustained state of inspection readiness across the organization and external partners
- Serving as the primary Inspection Lead and Host for FDA BIMO, MHRA, PMDA, EMA, and other Health Authority inspections
- Providing leadership and oversight for inspection readiness activities across clinical development, pharmacovigilance, regulatory affairs, data management, biometrics, medical affairs, and quality functions
- Establishing and maintaining inspection readiness strategies for CROs, investigator sites, pharmacovigilance vendors, laboratories, alliance partners, and other outsourced service providers
- Identifying compliance risks, developing mitigation strategies, and driving sustainable improvements that support successful inspection outcomes
- Providing guidance on global GCP and GVP regulatory requirements, emerging inspection trends, and Health Authority expectations throughout the product development lifecycle
- Leading inspection readiness assessments, mock inspections, and other proactive activities to evaluate organizational preparedness
- Leading cross-functional development of responses to observations, findings, CAPAs, effectiveness checks, and regulatory commitments
- Developing and communicating inspection readiness dashboards, KPIs, risk metrics, and trend analyses to Quality and Leadership
- Developing, implementing, and leading a risk-based GCP and Pharmacovigilance internal audit program
Vor Bio is advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor for autoimmune diseases, with Phase 3 results in myasthenia gravis and expansion into multiple indications including lupus, IgA nephropathy, and Sjögren's syndrome.
REQUIREMENTS:
- Bachelor's degree in life sciences, pharmacy, chemistry, or related field
- Minimum 12 years of experience in the regulated pharmaceutical and/or biotechnology industry, with at least 5 years 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 (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 required, approximately 25-50% including international travel
