Vice President, Quality and Regulatory Affairs

We need to output HTML fragment with sections: h3 for headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. The posting includes Position Summary (maybe About the role), Key Responsibilities, Qualifications, Preferred (maybe part of Qualifications), Leadership Profile (maybe Skills?), Key Near-Term Priorities (maybe part of Responsibilities or separate). We must not repeat job title as heading. No Job ID etc. Remove boilerplate. Must include only sections with real content. We need to decide which sections to include: About the role (position summary), Responsibilities (Key Responsibilities), Qualifications (Required and Preferred maybe combined), Skills (Leadership Profile maybe), Benefits/Pay/Schedule not present, so omit those sections. We must use

for each section heading. Use

• for any list of duties/requirements/benefits. Use

  for prose. We need to preserve all substantive information, not invent or summarize away detail. Must not create sections with filler like "commensurate with experience". So we only include sections where there is content. We need to parse the posting. Let's extract: Position Summary (first paragraph): "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." That's the summary. Key Responsibilities: many bullet points under headings: Quality Leadership, Regulatory Affairs Leadership, CMC & Cell Therapy Regulatory Strategy, Clinical Quality, Vendor & Consultant Oversight, Organizational Leadership. Each has sub-bullets. We need to output as a list (

  • ) for duties. Could flatten all responsibilities into a list, but we might want to keep subheadings? The instruction: Use
    • for any list of duties/requirements/benefits. It doesn't forbid headings inside list? Probably we should just produce a flat list of responsibilities. However we must preserve all substantive information; flattening may lose grouping but still preserve content. Could also produce nested lists? Not specified. Safer to produce a flat list with each responsibility as an
    • . Could also keep headings as

      before list? But they said use

      for section headings,

      • for any list,

        for prose. So within Responsibilities section, we can have a

        intro then

        • items. Similarly Qualifications: Required and Preferred. Could combine into list. Leadership Profile: could be Skills section. Key Near-Term Priorities: could be part of Responsibilities or separate section? It's a list of priorities for first 3-12 months. Could be its own section maybe "Near-Term Priorities". But allowed headings only from list: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. No "Near-Term Priorities". So we must fit into existing headings. Could treat as part of Responsibilities (duties) or maybe as part of Skills? Probably Responsibilities is appropriate: it's about what they will do early. So we can include those as list items under Responsibilities. Thus sections: About the role (position summary), Responsibilities (all responsibilities + near-term priorities), Qualifications (required + preferred), Skills (Leadership Profile). No Benefits/Pay/Schedule. We must not repeat job title as heading. So no heading for Vice President etc. Now produce HTML:

          About the role

          ... (the summary)

          Responsibilities

          • 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.
          • Oversee change controls.
          • Oversee out-of-specification / out-of-trend investigations.
          • Oversee product complaints.
          • Oversee document control.
          • Oversee training systems.
          • Oversee supplier qualification.
          • Oversee internal and external audits.
          • Oversee batch records.
          • Oversee product disposition and release.
          • Oversee 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.
          • 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.
          • Lead preparation and review of FDA information requests.
          • Lead preparation and review of meeting packages.
          • Lead preparation and review of annual reports.
          • Lead preparation and review of clinical protocol amendments.
          • Lead preparation and review of Investigator's Brochures.
          • Lead preparation and review of CMC regulatory submissions.
          • Lead preparation and review of 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.
          • Provide regulatory and Quality leadership for cell therapy manufacturing and CMC development.
          • Partner with Technical Operations on manufacturing process development.
          • Partner with Technical Operations on process qualification and validation strategy.
          • Partner with Technical Operations on analytical method development and validation.
          • Partner with Technical Operations on specifications.
          • Partner with Technical Operations on stability programs.
          • Partner with Technical Operations on raw material controls.
          • Partner with Technical Operations on comparability.
          • Partner with Technical Operations on manufacturing site changes.
          • Partner with Technical Operations on technology transfer.
          • Partner with Technical Operations on 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.
          • 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.
          • 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.
          • 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.
          • 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.

          Qualifications

          • 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.
          • 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.

          Skills

          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.