Associate Director, Global Quality System & Compliance

Revolution Medicines•Redwood City, CA

23h•Hybrid

About The Position

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: Provide strategic and operational leadership to scale and globalize the Quality Management System (QMS), establishing a harmonized, flexible framework that supports international growth and regulatory compliance. Lead oversight and expansion of core quality systems across global sites, including document control, GxP training, quality events, supplier management, audits, and batch release. Partner with regional teams (including Japan, Europe & other global regions) to integrate local regulatory requirements into the global QMS while maintaining global consistency. Establish and govern global quality procedures, including policies, SOPs, and standardized processes to ensure compliance and operational efficiency. Ensure inspection readiness and lead support for global health authority inspections, regulatory submissions, and product launches. Oversee global quality metrics, compliance monitoring, and management review processes; drive proactive identification, escalation, and mitigation of quality risks. Provide governance for electronic quality and validated GxP systems (e.g., Veeva Vault Quality), ensuring they effectively support global operations. Collaborate cross-functionally to build and sustain a scalable quality infrastructure aligned with organizational growth and global expansion. Champion a culture of continuous improvement and quality excellence across the enterprise.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related discipline (advanced degree preferred).
Minimum of 10+ years of experience in Quality within the pharmaceutical or biotechnology industry, including leadership of global quality systems.
Demonstrated experience establishing, leading, and maintaining a global Quality Management System (QMS) across multiple regions.
Proven ability to influence and align senior stakeholders and executive leadership on quality strategy and risk-based decision making.
Deep knowledge of global GxP regulations and experience ensuring compliance across international markets (e.g., FDA, EMA, PMDA).
Proven track record supporting global regulatory filings, approvals, inspections, and post-market quality obligations.

Nice To Haves

Experience building or transforming global QMS in a growing organization.
Prior interaction with FDA, EMA, PMDA, and other global health authorities.
Experience supporting commercial product launches and lifecycle management.

Responsibilities

Provide strategic and operational leadership to scale and globalize the Quality Management System (QMS), establishing a harmonized, flexible framework that supports international growth and regulatory compliance.
Lead oversight and expansion of core quality systems across global sites, including document control, GxP training, quality events, supplier management, audits, and batch release.
Partner with regional teams (including Japan, Europe & other global regions) to integrate local regulatory requirements into the global QMS while maintaining global consistency.
Establish and govern global quality procedures, including policies, SOPs, and standardized processes to ensure compliance and operational efficiency.
Ensure inspection readiness and lead support for global health authority inspections, regulatory submissions, and product launches.
Oversee global quality metrics, compliance monitoring, and management review processes; drive proactive identification, escalation, and mitigation of quality risks.
Provide governance for electronic quality and validated GxP systems (e.g., Veeva Vault Quality), ensuring they effectively support global operations.
Collaborate cross-functionally to build and sustain a scalable quality infrastructure aligned with organizational growth and global expansion.
Champion a culture of continuous improvement and quality excellence across the enterprise.