Executive Director, GxP Quality and Compliance

Revolution Medicines; San Francisco (CA); On-site; USD 265,000 - 331,000; Full time

Job summary

Revolution Medicines is seeking an Executive Director, GxP Quality & Compliance to define and lead global GxP strategy across clinical and commercial programs, ensuring regulatory alignment and inspection readiness.

You will shape enterprise quality systems, manage risk, and collaborate with cross-functional partners to support growth, product launches, and expansion into new markets.

Qualifications

• 15+ years of progressive experience in GxP Quality and Compliance in pharma/biotech.
• 8+ years in executive or senior leadership roles overseeing global quality.
• Proven success leading regulatory inspections and maintaining inspection readiness.
• Strong leadership, communication, and strategic planning abilities.
• Willingness to travel up to 15% for audits and meetings.

Responsibilities

• Develop and execute the global GxP Compliance strategy across clinical and commercial programs.
• Provide executive leadership for Quality Compliance, driving a culture of quality.
• Ensure enterprise-wide compliance with FDA/EMA/ICH and other global regulations.
• Lead regulatory inspections, health authority interactions, and readiness activities.
• Direct QMS strategy, governance, and continuous improvement initiatives.
• Oversee risk management and strategic compliance decisions at the executive level.

Skills

Leadership

Communication

Strategic planning

Cross-functional collaboration

People skills

Education

PhD or MS in life sciences

Advanced degree in related discipline

Job description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity

The Executive Director, GxP Quality & Compliance is a senior leadership role responsible for defining and executing the global compliance strategy across clinical development programs and commercial products. This role will ensure adherence to applicable regulatory requirements, industry standards, and company policies governing GxP activities. The role provides strategic oversight of inspection readiness, quality systems, compliance risk management, supplier oversight and compliance, and enterprise-wide GxP initiatives. In this role, you will shape enterprise quality strategy, influence executive decision-making, and build a world-class compliance organization that supports sustainable growth and operational excellence.

This position serves as a key advisor to senior leadership on global compliance policy and strategy and reports to the Vice President, Global Quality.

Key Responsibilities

• Develop and execute the organization’s global GxP Compliance strategy, ensuring alignment with corporate objectives, business priorities, and global regulatory requirements.
• Provide executive leadership for the Quality Compliance function, fostering a culture of quality, integrity, accountability, and continuous improvement across the organization.
• Ensure enterprise-wide compliance with FDA, EMA, MHRA, Health Canada, ICH, and other applicable global regulations, including cGMP, GCP, GLP, GDP, and GVP, as applicable.
• Serve as the executive lead for regulatory inspections, health authority interactions, and inspection readiness activities, ensuring the organization maintains a continuous state of readiness.
• Direct the strategy, governance, implementation, and continuous improvement of the Quality Management System (QMS), including policies, procedures, standards, and compliance processes.
• Lead enterprise compliance risk management by proactively identifying, assessing, and mitigating regulatory and quality risks while advising executive leadership on strategic compliance decisions.
• Partner collaboratively with PDM, Quality Assurance, Regulatory Affairs, Clinical Development, Life Cycle Management, and Information Technology to ensure consistent GxP compliance across all business functions.
• Establish, monitor, and communicate quality and compliance metrics, dashboards, and key performance indicators (KPIs) to executive leadership and governance committees.
• Ensure compliance with data integrity requirements, computerized system validation (CSV), electronic Quality Management Systems (eQMS), and emerging digital technologies.
• Champion operational excellence and continuous improvement initiatives that strengthen compliance, enhance efficiency, and improve inspection readiness and organizational performance.
• Provide strategic compliance oversight of supplier quality and audit programs managed by GxP Vendor Management, ensuring risk-based governance, visibility to significant findings, and alignment with enterprise compliance priorities.
• Advise GCP and GMP QA Operations on deviation, CAPA, and quality event governance, with focus on systemic risk, effectiveness of corrective actions, and escalation of significant compliance trends.
• Support organizational growth initiatives, including product launches, technology transfers, acquisitions, business integrations, commercialization, and expansion into new global markets.

Required Skills, Experience and Education

• Advanced degree in life sciences, pharmacy, chemistry, or a related scientific discipline (PhD, MS, or equivalent preferred).
• 15+ years of progressive experience in GxP Quality and Compliance within the pharmaceutical, biotechnology, medical device, or related life sciences industry with extensive knowledge of FDA regulations, ICH Guidelines, EU GMP, and global GxP requirements.
• 8+ years of executive or senior leadership experience leading global quality and compliance organizations.
• Demonstrated success leading regulatory inspections and maintaining inspection readiness for FDA and international regulatory agencies.
• Excellent leadership, communication, strategic planning, cross-functional collaboration and people skills, with the ability to influence stakeholders at all levels.
• This role may require occasional travel (up to 15%) for audits, inspections, and meetings.
• Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

Preferred Skills

• Experience leading global GxP compliance programs across both clinical development and commercial product environments, including inspection readiness, launch readiness, and post-approval compliance oversight.
• Demonstrated success building and scaling enterprise compliance governance in a rapidly growing, highly outsourced biotechnology or oncology-focused organization.
• Experience advising executive leadership on global compliance risks, regulatory inspection strategy, quality system maturity, and enterprise-level remediation priorities.

The base pay salary range for this full‑time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job‑related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Base Pay Salary Range

$265,000 - $331,000 USD

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

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