Vice President, Quality Assurance

About the role

Cellphire Therapeutics is seeking a Vice President of Quality Assurance to lead its global quality strategy across GxP environments. Based in Rockville, Maryland, the role will ensure regulatory compliance while supporting clinical and commercial operations for its innovative biologics platform.

Key responsibilities

• Establish and lead a comprehensive Quality Management System covering GMP, GCP and GLP.
• Act as the primary quality representative during FDA, EMA and other regulatory inspections and audits.
• Oversee quality assurance for both clinical‑stage and commercial biologics manufacturing.
• Build and mentor a high‑performing QA team.
• Prepare the organization for BLA/NDA filings and product commercialization.
• Drive continuous‑improvement, risk‑management and compliance initiatives.
• Collaborate with CMC, regulatory affairs and operations to align quality across the product lifecycle.

Required profile

• Bachelor’s degree in life sciences (advanced degree preferred).
• 15+ years of quality experience in biotech or pharma, preferably with biologics.
• Proven track record with FDA inspections and regulatory submissions.
• Strong leadership and organizational influence.
• Experience with cell therapy, blood products or platelet‑based technologies is a plus.

Required skills

• GMP, GCP and GLP compliance.
• Quality Management System (QMS) implementation.
• FDA inspection processes.
• Regulatory submission preparation (BLA/NDA).
• Risk management and continuous‑improvement methodologies.

What we offer

• Competitive base salary plus bonus.
• Equity participation.
• Comprehensive medical, dental and vision coverage.
• 401(k) plan with company match.
• Generous paid time off and holidays.