VP Quality & Regulatory Affairs

6550 Dumbarton Cir
Fremont, CA 94555, USA

The VP, Quality & Regulatory Affairs is an executive leadership role responsible for defining and executing the strategic direction for both the Quality and Regulatory functions. This executive leader provides strategic and operational oversight of Quality Assurance (QA), Quality Control (QC), compliance, validation, supplier quality, and quality systems across product development, clinical manufacturing, and commercial manufacturing activities.

The VP, Quality & Regulatory Affairs partners closely with CMC, Manufacturing, Clinical Development, Supply Chain, R&D, and external partners to ensure that all products are developed and manufactured in accordance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and applicable FDA, EMA, ICH, and other global regulations to meet the highest standards of product safety, efficacy, and compliance.

Provides expertise in translating regulatory requirements into practical, workable plans. Acts as the main liaison with global health authorities.

As a member of the executive leadership team, the VP, Quality & Regulatory Affairs fosters a culture of quality, continuous improvement, operational excellence, patient focus, accountability, and cross-functional collaboration to support the company's strategic objectives.

• Provide strategic leadership and advise executive management and the Board on quality, compliance, regulatory, and quality culture. Develop and execute the company's global Quality strategy aligned with corporate objectives.
• Maintain and improve a robust Quality Management System (QMS) to support product development, clinical manufacturing, and commercial operations.
• Serve as the executive leader responsible for company-wide culture of quality, compliance, and continuous improvement.
• Support corporate growth, technology transfers, new product introductions, and commercialization.
• Provide executive oversight of Quality Assurance activities, including but not limited to:
  Quality Systems, Document Control, Training, Change Control, Deviations, CAPA (including timely implementation and closure), Audits (internal, external and supplier), Risk Management, and Product Release
• Ensure compliance with FDA, EMA, and other global regulatory authorities.
• Lead preparation of Quality related content (specifications, stability data, etc.) for all regulatory submissions.
• Provide executive oversight of Quality Control activities including but not limited to:
  Analytical testing, Method Transfer, Stability programs and ensure laboratory operations comply with GMP and data integrity requirements.
• Ensure company readiness for regulatory inspections and serve as executive quality representative during FDA, EMA, and other regulatory inspections.
• Ensure quality system metrics and key process indicators are established and used to drive compliance and continuous improvement.
• Determine appropriate Quality organization structure, staffing and resource requirements to support business objectives.
• Provide mentorship to staff related to diverse regulatory requirements, practices and customs.
• Provide leadership to direct report(s) and regulatory guidance to project teams.

• Extensive knowledge of global GMP regulations, FDA, EMA, ICH, and international quality standards.
• Proven ability to maintain, improve, and lead Quality Management Systems (QMS) in biotechnology or pharmaceutical environments.
• Demonstrated success leading regulatory inspections and managing regulatory compliance.
• Strong expertise in Quality Assurance, Quality Control, validation, supplier quality, and risk management.
• Experience overseeing quality activities across product development, clinical manufacturing, commercial manufacturing, and technology transfer.
• Excellent leadership skills with a track record of building, mentoring, and developing high-performing teams.
• Strategic thinker capable of aligning quality objectives with overall business goals while maintaining operational excellence.
• Strong cross-functional collaboration and stakeholder management skills, with the…