What are the responsibilities and job description for the Vice President, Quality position at NWRPros?
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Our client is a cutting-edge genomic medicine company advancing therapies across multiple technology platforms, including gene therapy, cell therapy, and genome editing. They are building a robust pipeline to address patients with serious and life-limiting conditions. This is a unique opportunity to join a highly innovative organization at the forefront of translating science into impactful medicines.Job SummaryThe Vice President of Quality will lead and evolve the Quality function across the enterprise. This executive will be responsible for ensuring best-in-class Quality oversight from early development through commercialization, covering GxP operations, Quality Systems, Quality Assurance, R&D/Clinical Quality, and Manufacturing Quality.
This role reports to the Chief Technical Officer, with visibility to the CEO and Executive Leadership Team. The VP of Quality will serve as a trusted advisor and accountable Quality leader, shaping strategy, leading regulatory readiness, and mentoring a high-performing team.Key Responsibilities
The anticipated salary range is for candidates who will work in the company’s California offices. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience with the job, type and length of experience within the industry, education, etc. This salary range may not apply to remote positions that work in other states.
Apply at NWRPros Here
Our client is a cutting-edge genomic medicine company advancing therapies across multiple technology platforms, including gene therapy, cell therapy, and genome editing. They are building a robust pipeline to address patients with serious and life-limiting conditions. This is a unique opportunity to join a highly innovative organization at the forefront of translating science into impactful medicines.Job SummaryThe Vice President of Quality will lead and evolve the Quality function across the enterprise. This executive will be responsible for ensuring best-in-class Quality oversight from early development through commercialization, covering GxP operations, Quality Systems, Quality Assurance, R&D/Clinical Quality, and Manufacturing Quality.
This role reports to the Chief Technical Officer, with visibility to the CEO and Executive Leadership Team. The VP of Quality will serve as a trusted advisor and accountable Quality leader, shaping strategy, leading regulatory readiness, and mentoring a high-performing team.Key Responsibilities
- Develop and execute a comprehensive Quality strategy that supports corporate objectives and fosters a culture of quality and continuous improvement.
- Lead preparation for and management of global regulatory inspections (FDA, EMA, MHRA, etc.) across GMP, GCP, and GLP functions.
- Oversee Quality Systems, policies, procedures, and training programs to ensure compliance with global regulatory requirements.
- Provide Quality oversight for R&D and Clinical activities from preclinical through commercialization, including compliance with ICH, GCP, GLP, and GPvP.
- Partner with Research, Clinical Operations, Technical Development, Manufacturing, Regulatory, Supply Chain, and external providers (CROs, CDMOs, and service partners).
- Drive QA/QC activities including product release, deviation/change control, GMP documentation review, supplier management, and stability programs.
- Lead, mentor, and grow a diverse Quality team (spanning specialists through directors, including consultants).
- Represent the Quality organization with internal leadership and external stakeholders, including regulatory authorities.
- Serve as a key member of the Technical Operations Leadership Team, providing input into strategy, budgets, and program execution.
- Bachelor’s degree in a life sciences or engineering discipline required; advanced degree (Ph.D. or Master’s) strongly preferred.
- 15 years of experience in biotechnology or pharmaceuticals, with significant exposure to gene therapy, biologics, or advanced therapy medicinal products (ATMPs).
- 8 years in GxP Quality leadership roles, including direct people management.
- Experience in both Quality Assurance and Research/Development environments, ideally including clinical quality oversight.
- Strong background in GMP manufacturing and Quality Systems, including commercial readiness.
- Successful track record leading regulatory inspections and contributing to regulatory submissions.
- Demonstrated ability to operate at the executive level, influence senior stakeholders, and present to leadership and health authorities.
- Exceptional communication and stakeholder management skills.
- Strong executive presence and ability to gain credibility across the organization.
- Commercial experience, ideally contributing to late-stage development and product launch.
- Hands-on leadership style, with the ability to mentor teams while engaging directly when needed.
- Ability to work onsite in the San Francisco Bay Area (hybrid, with regular site presence).
- Willingness to travel domestically (up to 10%).
The anticipated salary range is for candidates who will work in the company’s California offices. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience with the job, type and length of experience within the industry, education, etc. This salary range may not apply to remote positions that work in other states.
Apply at NWRPros Here