Vice President Quality and Regulatory Affairs

Vice President Quality and Regulatory Affairs

Location Germantown, MD
Hybrid

Type Direct Hire

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.

• 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 Document control Training systems 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.
• 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. 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:
  Process qualification and validation strategy Analytical method development and validation Specifications Stability programs Raw material controls Manufacturing site changes Technology transfer Supply chain controls.
• Assess regulatory impact of manufacturing changes…