Director, U.S. Commercial QA Lead (GMP)
Regulatory Affairs | Hybrid/Remote – U.S. (Eastern Time Zone preferred)
Pharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated angioedema, 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.
Location
At Pharvaris we promote and enable a flexible hybrid work environment, where our employees choose from where (and, to some extent, when) they prefer to work. Whilst this is a remote/hybrid role, you must be in the U.S. (Greater Boston area), as we like you to be on-site (Lexington, MA) 1-2 days per week on average.
Main 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.
Preferred skills and qualifications
Education
- Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related field required. Advanced degree preferred.
Experience
- 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).
Technical Expertise
- 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.
We are looking for someone that has
- Strong planning and project management skills, solutions-oriented mindset, ready and willing to “roll up sleeves” and directly drive implementation and execution of projects.
- Proactive thinking and leadership in execution of complex project execution, ability to early identify opportunities and risks as well as effective approaches to leverage/mitigate them, by also being willing to take reasonable risks.
- Ability to cope under pressure with conflicting priorities and to maintain an action- and result-oriented approach, high flexibility and ability to handle ambiguity & changes and operate in a rapidly-evolving environment.
- Strategic thinking, business acumen, analytical mindset with strong attention to details, with proven ability to motivate, influence, negotiate, and collaborate with internal and external stakeholders through efficient management of relationship within a cross-functional matrix.
- Excellent communication skills, ability to successfully and positively manage interactions with internal and external stakeholders, and act as unifier and promoter of cohesiveness within functional and cross-functional Teams.
- Knowledge of and strict adherence to applicable Healthcare Compliance and Regulatory standards, guidelines, and policies as applicable to Medical Affairs and to cross-functional Teams.
- Promotes transparency, active listening and understanding, speak-up culture and knowledge and information sharing within the Medical Affairs/Patient Advocacy as well as cross-functional Teams.
What we offer
At Pharvaris we promote and enable a flexible hybrid work environment, where employees have flexibility in choosing their work location and, to some extent, their working hours. This flexibility includes the option to work remotely or from our office (Lexington, MA). We prefer this role to be on-site 1-2 days per week.
Pharvaris is committed to fair and equitable compensation practices. The base salary range for this role is $195,000 -$225,000 per year. Actual compensation will depend on various factors, including but not limited to depth of experience, skill set, overall performance, and education. Pharvaris believes in providing a competitive compensation and benefits package. Base salary is just one component of our competitive total rewards strategy. We also offer annual performance bonus eligibility, equity (RSUs) as a long-term incentive, a comprehensive range of market-competitive benefits, uncapped paid time off, and other incentive compensation plans (where applicable).
To apply, please submit your application through the BambooHR link below: https://pharvaris.bamboohr.com/careers/28
