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, 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.