Vice President, Quality Assurance
Washington, District of Columbia, United States · Full Time
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- Experience
- 15+ yrs
- Salary
- USD 220,000 – USD 300,000 / year
- Openings
- 1
- Posted
- 1 week ago
- Work mode
- In office
- Education
- Bachelor's degree in life sciences
- Eligibility
- Senior quality professionals with extensive biotech or pharmaceutical experience, especially candidates familiar with biologics, cell therapy, blood products, or platelet-based technologies, are the intended fit for this role.
- Resume
- Required to apply
Where you'll work
Job description
About the Company
Cellphire Therapeutics, Inc. is a biotechnology company headquartered in Rockville, Maryland. It is developing next-generation treatments using proprietary cell stabilization technology for a broad set of cell types, including platelets, with the goal of creating life-saving therapies. Its lead program, Thrombosomes®, is a freeze-dried hemostatic product derived from human platelets and is presently in a Phase I clinical trial. The company’s platform may also be useful in areas such as trauma care, wound treatment, imaging, targeted drug delivery, and regenerative medicine.
Benefits and Compensation
- Competitive base pay plus bonus opportunity
- Equity participation
- Full medical, dental, and vision coverage
- 401(k) plan with company matching
- Paid time off and company holidays
The role offers a salary range of USD 220,000 to USD 300,000 per year.
Role Summary
The Vice President of Quality Assurance will define, build, and expand Cellphire’s quality framework across global GxP operations. This leader will ensure the organization remains aligned with FDA, EMA, and other applicable regulatory expectations while supporting efficient clinical and commercial execution. The position also requires close collaboration with teams across development, manufacturing, and supply chain to make quality a core part of the business.
Key Responsibilities
- Create and oversee the Quality Management System across GMP, GCP, and GLP environments.
- Act as the main quality contact during inspections and audits by regulators and other stakeholders.
- Lead quality assurance activities for both clinical-stage and commercial biologics production.
- Recruit, develop, and guide the QA organization while promoting a strong performance-driven culture.
- Prepare the business for BLA and NDA submissions as well as commercialization activities.
- Advance ongoing improvement, risk mitigation, and compliance programs.
- Work closely with CMC, regulatory, and operations teams to keep quality aligned from end to end.
- Perform the essential duties of the role, with or without reasonable accommodation, in line with the Americans with Disabilities Act (ADA).
Qualifications
- Bachelor’s degree in life sciences; an advanced degree is preferred.
- At least 15 years of quality experience in biotech or pharmaceutical settings, with biologics experience strongly preferred.
- Hands-on exposure to FDA inspections and regulatory filings.
- Proven ability to lead teams and influence across functions and levels.
Preferred Background
- Experience in cell therapy, blood products, or platelet-based technologies.
- Background supporting transitions from early development to commercial scale.
- Experience establishing a Quality Management System from the ground up in an emerging biotech company.
Additional Information
Job duties, reporting relationships, and scope may be adjusted over time to meet business needs. Cellphire Therapeutics, Inc. is an equal opportunity employer.
Thrombosomes® is not approved or licensed by the U.S. Food and Drug Administration (FDA); it has been authorized for emergency use under an Emergency Use Authorization (EUA) only for the duration of the emergency-use declaration.