Job Details

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.