Vice President Regulatory Affairs Quality Assurance

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.