VP, Quality Assurance and Regulatory Affairs

Position Summary Our Startup Client is seeking an experienced Vice President of Quality & Regulatory Affairs to lead the Quality and Regulatory functions for a clinical-stage biotechnology company developing innovative cell-based therapies. This executive will have overall responsibility for establishing and maintaining a phase-appropriate Quality Management System, providingstrategic regulatory leadership, and ensuring compliance across clinical development, manufacturing, testing, and external partners. The VP will serve as a key member of the leadership team and will work closely with Clinical, CMC/Technical Operations, Manufacturing, R&D, and external partners to advance programs through clinical development and toward commercialization. The successful candidate should be highly hands-on and comfortable operating in a small, fast-paced biotechnology company.This role requires both strategic leadership and the ability to independently assess issues, make risk-based recommendations, and drive execution. The VP will hold independent Quality authority for product disposition and release, maintained separately from Manufacturing and Technical Operations. Key Responsibilities Quality Leadership • Provide executive leadership and oversight for Quality Assurance and Quality Control. • Establish, maintain, and continuously improve a phase-appropriate Quality Management System (QMS) supporting clinical-stage cell therapy development. • Ensure compliance with applicable GMP, GCP, GLP, and other relevant FDA regulatory requirements. • Provide independent Quality oversight of manufacturing, testing, release, clinical supply, and vendor activities. • Maintain appropriate Quality independence from Manufacturing and Technical Operations, including independent authority for product disposition and release. Oversee: – Deviations and investigations – Change controls – Out-of-specification / out-of-trend investigations – Product complaints – Document control – Training systems – Supplier qualification – Internal and external audits – Batch records – Product disposition and release – Quality risk management • Ensure Quality systems evolve appropriately as the company progresses from early clinical development toward later-stage development and commercialization. Establish clear Quality metrics and regularly communicate significant risks, trends, and remediation plans to executive leadership. Regulatory Affairs Leadership • Develop and execute the company's US regulatory strategy, with expansion into global regulatory activities as programs advance. • Serve as a primary strategic interface with the FDA and other regulatory authorities. Lead preparation and review of: – IND submissions and amendments – FDA information requests – Meeting packages – Annual reports – Clinical protocol amendments – Investigator's Brochures – CMC regulatory submissions – Safety-related regulatory communications • Provide strategic guidance on regulatory pathways for cell therapy programs, including early clinical development, dose escalation, manufacturing changes, comparability, and later-stage development. • Partner closely with Clinical, CMC, Preclinical, and R&D teams to ensure regulatory strategy is integrated into development plans. • Translate regulatory feedback into clear, actionable internal plans. • Maintain productive and transparent interactions with regulatory authorities. CMC & Cell Therapy Regulatory Strategy • Provide regulatory and Quality leadership for cell therapy manufacturingand CMC development. Partner with Technical Operations on: – Manufacturing process development – Process qualification and validation strategy – Analytical method development and validation – Specifications – Stability programs – Raw material controls – Comparability – Manufacturing site changes – Technology transfer – Supply chain controls • Assess regulatory impact of manufacturing changes and determine appropriate submission and implementation strategies. • Ensure manufacturing controls and documentation are appropriate for the clinical stage while supporting progression toward commercial readiness. Clinical Quality • Provide Quality oversight of clinical development activities. • Ensure appropriate GCP systems and vendor oversight are established. • Partner with Clinical Operations on qualification and oversight of CROs, clinical sites, laboratories, and other service providers. • Support inspection readiness as the clinical program expands. Vendor & Consultant Oversight • Establish a structured approach for qualification and oversight of CROs, CDMOs, testing laboratories, consultants, and other critical vendors. • Evaluate external recommendations independently and ensure that final Quality and Regulatory strategies reflect the company's scientific, operational, and business objectives. • Build sufficient internal expertise so that critical regulatory and Quality decisions are owned by the company rather than outsourced to consultants. • Manage external consultants selectively to supplement, rather than replace, internal leadership. Organizational Leadership • Build and mentor a high-performing Quality and Regulatory organization appropriate for the company's stage of development. • Lead and develop existing QA/QC personnel and establish clear roles, responsibilities, decision rights, and escalation pathways. • Recruit additional Quality and Regulatory personnel as the organization grows. • Develop future leaders within the Quality organization. • Promote a culture of accountability, scientific rigor, collaboration, and practical risk management. • Work collaboratively across functions while maintaining appropriate Quality independence. Qualifications Required • Bachelor's degree in life sciences, engineering, pharmacy, or related discipline; advanced degree preferred. • Typically 15+ years of progressive experience in biotechnology, pharmaceutical, or cell/gene therapy development, including significant leadership experience. • Direct Quality and/or Regulatory leadership experience with cell therapy, gene therapy, or other advanced / complex biological products — required . • Demonstrated experience leading Quality and/or Regulatory functions in a clinical-stage biotechnology company. • Strong understanding of GMP requirements for clinical manufacturing. • Experience with IND-stage programs and direct interaction with FDA. • Demonstrated experience developing regulatory strategy and responding to FDA questions or information requests. • Strong knowledge of Quality systems, including deviation management, CAPA, change control, supplier qualification, audits, and product disposition. • Experience supporting clinical manufacturing and release of investigational products. • Experience managing CROs, CDMOs, laboratories, and regulatory/Quality consultants. • Ability to operate effectively in a small company where executives are expected to work both strategically and hands-on. Preferred • Advanced degree (MS, PhD, PharmD, MD, or equivalent). • Prior leadership experience specifically in cell therapy, regenerative medicine, xenotransplantation, or other advanced biologic modalities. • Experience supporting products from Phase 1 through later-stage clinical development. • Experience establishing or significantly upgrading a Quality Management System in a growing biotechnology company. • Experience with regulatory strategy for manufacturing changes and comparability. • Experience participating in FDA meetings and regulatory inspections. • Experience preparing an organization for commercial-stage GMP requirements. Leadership Profile The ideal candidate will: • Exercise independent scientific and regulatory judgment. • Be comfortable challenging assumptions while remaining pragmatic and solution-oriented. • Understand the distinction between regulatory requirements, regulatory precedent, and conservative industry practice. • Identify practical paths forward rather than simply identifying compliance risks. • Communicate clearly with executives and technical teams. • Be willing to make decisions with incomplete information while appropriately managing risk. • Balance patient safety, regulatory compliance, development speed, and business priorities. • Operate effectively without a large corporate infrastructure. • Take ownership of issues and drive them through resolution.