Vice President Quality Assurance

Cellphire Therapeutics, Inc.; Ruston, Washington (WA, District of Columbia); On-site; USD 220,000 - 300,000; Full time

Benefits offered by this job

Competitive base salary+bonus

Equity opportunities

Medical, dental, and vision

401(k) with company match

Generous PTO and holidays

Job summary

Cellphire Therapeutics, Inc. is a Rockville, Maryland-based biotech company focused on cell stabilization technologies for broad therapeutic applications.

The VP, Quality Assurance will build and scale a global quality program spanning development to commercial manufacturing, ensuring FDA/EMA compliance and patient safety. The role requires 15+ years in biotech/pharma quality, leadership across GMP/GLP/GCP, and strong collaboration with Regulatory Affairs, Manufacturing, and Supply Chain.

Qualifications

• 15+ years in Quality within biotech/pharma (biologics strongly preferred)
• Experience with FDA inspections and regulatory submissions
• Strong leadership and organizational influence skills
• Cell therapy, blood products, or platelet-based technologies
• Early-stage to commercial scale transitions
• Building QMS from ground up in emerging biotech

Responsibilities

• Develop and execute Cellphire's enterprise-wide Quality strategy, establishing a scalable quality org that supports transition from clinical-stage development through commercial manufacturing
• Build, lead, and mentor a high-performing Quality organization across functions with accountability and continuous improvement
• Establish, implement, and enhance the QMS across GMP, GLP, GCP operations for robust quality systems and governance
• Provide executive leadership for QA activities supporting product development, tech transfer, manufacturing, analytics, distribution, and commercialization
• Serve as the primary Quality representative during FDA/EMA inspections and customer audits, leading readiness initiatives and regulatory outcomes
• Partner with Manufacturing, Regulatory Affairs, Supply Chain, Clinical Operations, and Exec Leadership to identify risks and embed quality across the lifecycle
• Oversee internal manufacturing and external partners to ensure consistent quality standards across the supply chain
• Lead quality strategy for regulatory submissions (IND amendments, BLA filings) and commercial readiness
• Drive enterprise risk management, deviations, CAPAs, change control, supplier quality, and continuous improvement for inspections readiness
• Provide strategic guidance on quality and regulatory matters to executives, balancing innovation and patient safety
• Maintain relationships with regulators and industry stakeholders and stay current on global regulations

Skills

Quality leadership

Regulatory inspections

GxP compliance

Cross-functional leadership

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

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

• Develop and execute Cellphire's enterprise-wide Quality strategy, establishing a scalable quality organization that supports the company's transition from clinical-stage development through commercial manufacturing while ensuring patient safety, product quality, and regulatory compliance.
• Build, lead, and mentor a high-performing Quality organization, fostering a culture of accountability, operational excellence, continuous improvement, and quality ownership across all functions.
• Establish, implement, and continuously enhance the Quality Management System (QMS) across GMP, GLP, and GCP operations, ensuring robust quality systems, effective governance, and sustainable compliance with global regulatory expectations.
• Provide executive leadership for all Quality Assurance activities supporting product development, technology transfer, manufacturing, analytical testing, distribution, and commercialization of Cellphire's innovative biologic therapies.
• Serve as the company's primary Quality representative during FDA, EMA, and other global regulatory inspections, customer audits, and due diligence activities while leading inspection readiness initiatives and ensuring successful regulatory outcomes.
• Partner closely with Manufacturing, Technical Operations, Regulatory Affairs, Supply Chain, Clinical Operations, and Executive Leadership to proactively identify quality risks, resolve complex issues, and integrate quality throughout the product lifecycle.
• Establish quality oversight for internal manufacturing operations as well as external CMOs, CDMOs, laboratories, suppliers, and other strategic partners, ensuring consistent quality standards across the entire supply chain.
• Lead quality strategy for regulatory submissions, including IND amendments, BLA filings, and commercial readiness activities, ensuring all quality systems and documentation support successful product approvals.
• Drive enterprise risk management, quality metrics, deviation investigations, CAPAs, change control, supplier quality, complaint handling, and continuous improvement initiatives that strengthen operational performance and inspection readiness.
• Provide strategic guidance to executive leadership on quality, compliance, and regulatory matters, helping shape business decisions while balancing innovation, speed, operational efficiency, and patient safety.
• Build and maintain strong relationships with regulatory agencies, external partners, and industry stakeholders while remaining current on evolving global regulations, industry trends, and emerging best practices.
• Champion a company-wide quality culture where compliance, integrity, collaboration, and continuous improvement are embedded into every stage of product development and manufacturing.
• 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 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.