Who We Are
Cellphire Therapeutics, Inc. is a Rockville, Maryland-based biotechnology company developing next-generation therapeutics. The company is applying its proprietary cell stabilization technology to all cell types, including platelets, to develop lifesaving products. Its lead product, Thrombosomes®, a freeze-dried hemostatic agent derived from human platelets, is currently in a Phase I clinical trial. Cellphire’s technology has potential applications across a wide range of medical applications, from trauma to wound care, imaging, targeted drug delivery, and regenerative medicine. www.cellphire.com
Benefits That Matter
- Competitive base salary + bonus
- Equity opportunities
- Comprehensive medical, dental, and vision
- 401(k) with company match
- Generous PTO and holidays
Position Overview
The VP, Quality Assurance is responsible for building, leading, and scaling Cellphire's global quality strategy across GxP environments. This role ensures compliance with FDA, EMA, and other regulatory standards while enabling efficient clinical and commercial operations. The VP will partner cross-functionally to embed quality into development, manufacturing, and supply chain processes.
What You Will Do
- Establish and lead the Quality Management System (QMS) covering GMP, GCP, and GLP
- Serve as primary quality representative for regulatory inspections and audits
- Oversee QA for clinical-stage and commercial biologics manufacturing
- Build and lead QA team, fostering high-performance culture
- Ensure readiness for BLA/NDA filings and commercialization
- Drive continuous improvement, risk management, and compliance initiatives
- Partner with CMC, regulatory, and operations to ensure end-to-end quality alignment
- This position requires the ability to perform the essential job functions outlined above, with or without reasonable accommodation, in accordance with the Americans with Disabilities Act (ADA).
Ideally, you’ll have
- Bachelor's degree in life sciences; advanced degree preferred
- 15+ years in Quality within biotech/pharma (biologics strongly preferred)
- Experience with FDA inspections and regulatory submissions
- Strong leadership and organizational influence skills
You'll excel it if you have experience with
- Cell therapy, blood products, or platelet-based technologies
- Early-stage to commercial scale transitions
- Building QMS from ground up in emerging biotech
Pay Range USD $220,000.00 - USD $300,000.00 /Yr.
Disclaimer: Please note that job responsibilities, reporting lines, and duties outlined in this job description are subject to change to meet the evolving needs of the organization. Cellphire is an Equal Opportunity Employer.
Thrombosomes® has not been approved or licensed by the U.S. Food and Drug Administration (FDA) but has been authorized for emergency use under an Emergency Use Authorization (EUA). The product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use.
