Director, US Commercial QA Lead (GMP)
About The Position
Pharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to bradykinin-mediated angioedema patients who suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening. We have a culture built on the core values of considering others carefully, leading with trust, ensuring rigor and diversity of thought, and contributing freely. Our company is driven by individuals committed to developing breakthrough therapies which can have a real impact on people’s lives. If you are looking for a place where your work can have meaning, and you can make a difference – Pharvaris is the place for you! As we are expanding the quality assurance team, we are looking for a Quality Assurance – Commercial GMP, Director, to join our team and report to the Global Head of GxP Quality.
Requirements
- Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field required.
- 12+ years of progressive commercial GMP Quality experience.
- 5+ years of leadership and people management experience in commercial GMP QA.
- Direct FDA inspection experience (required).
- Experience supporting commercial product launches (required).
- Experience in virtual and outsourced manufacturing models (required).
- Strong working knowledge of FDA 21 CFR Parts 210/211.
- Practical application of ICH Q9, Q10, Q7a and Q12.
- Commercial deviation, complaint, and post‑approval change management.
- Data integrity and computerized system compliance.
- Risk‑based supplier and CMO oversight.
Nice To Haves
- Advanced degree preferred.
Responsibilities
- Lead U.S. commercial GMP Quality Assurance activities, providing independent oversight of manufacturing, supply, and distribution operations.
- Ensure compliance with FDA regulations (21 CFR Parts 210/211) and applicable ICH guidelines, maintaining ongoing inspection readiness.
- Oversee commercial product release and lifecycle quality management for U.S. markets.
- Provide quality oversight of CMOs, suppliers, and service providers, including quality agreements, supplier qualification, and risk-based audits.
- Serve as the Quality lead for FDA inspections and regulatory interactions, including response to observations and CAPA execution.
- Oversee management of quality issues, including deviations, OOS, complaints, investigations, and continuous improvement activities.
- Partner cross-functionally with Technical Operations, Supply Chain, Regulatory Affairs, and Commercial teams while maintaining Quality independence.
- Support launch readiness, scale-up, and post-approval changes for U.S. commercial products.
- Exercise independent Quality decision‑making authority, including escalation of compliance or patient safety risks and, where necessary, product hold or distribution decisions.
- Ensure robust commercial GMP quality systems are in place, including data integrity, documentation standards, and effective quality risk management.
- Drive a proactive quality mindset through effective use of metrics, trending, and continuous improvement to support reliable commercial supply.
Benefits
- annual performance bonus eligibility
- equity (RSUs) as a long-term incentive
- comprehensive range of market-competitive benefits
- uncapped paid time off
- other incentive compensation plans (where applicable)
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
11-50 employees
