Associate Director, Global Quality System & Compliance
$186k - $233kRevolution Medicines
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.
- 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.
- 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.
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