Position Summary 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, providing strategic 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 manufacturing and 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. Key Near-Term Priorities During the first 3-12 months, the VP of Quality & Regulatory Affairs will be expected to: * Assess the current Quality and Regulatory organization and define an appropriate future-state structure. * Strengthen management and oversight of the QA/QC organization. * Review and prioritize improvements to the company’s QMS. * Establish clear Quality governance and decision-making processes. * Assume internal ownership of regulatory strategy and reduce reliance on external regulatory consulting. * Support execution of the company’s Phase 1 clinical program. * Strengthen regulatory and Quality oversight of clinical manufacturing. * Establish a scalable vendor qualification and oversight program. * Develop a regulatory strategy supporting future manufacturing, process, material, and supply-chain changes. * Build an inspection-ready Quality culture appropriate for a growing clinical-stage cell therapy company.