Associate Director, Quality Systems Monitoring & Excellence

Revolution Medicines•Redwood City, CA

1d•$186,000 - $233,000•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: Lead the Global Quality Systems Monitoring & Excellence program to ensure effective governance, compliance, and continuous improvement across the Quality Management System (QMS). Drive global audit and regulatory inspection readiness by leading inspection planning, mock inspections, execution support, response coordination, and post-inspection remediation. Develop and monitor Quality KPIs/KQIs, analyze trends, identify systemic risks, and provide executive reporting through Quality Management Reviews (QMRs). Perform Quality System health assessments and effectiveness reviews to identify compliance gaps and drive sustainable improvements. Oversee CAPA governance related to internal audits & inspections, root cause analysis, effectiveness verification, and closure of audit and inspection commitments. Lead the management of critical quality issues and escalations, facilitate timely cross-functional investigations and remediation plans, and ensure effective resolution of compliance risks and regulatory commitments. Partner with cross-functional stakeholders to standardize, simplify, and optimize Quality processes while ensuring compliance with global GxP regulations. Lead regulatory intelligence activities and translate evolving global regulatory expectations into Quality System enhancements. Leverage AI, automation, data analytics, and digital Quality platforms to enhance compliance monitoring, executive reporting, and operational excellence. Build and lead a high-performing team while fostering a culture of quality, compliance, inspection readiness, and continuous improvement across the organization.

Requirements

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or a related scientific discipline; Master's degree preferred.
10+ years of progressive Quality Assurance/Quality Systems experience in the biotechnology, pharmaceutical, or medical device industry, including people leadership.
Strong knowledge of global GxP regulations, including FDA, EMA, ICH, and applicable international quality standards.
Demonstrated experience leading regulatory inspections, internal audits, Quality Management Reviews (QMRs), and Quality Systems governance.
Experience with electronic Quality Management Systems (eQMS), such as Veeva Vault or equivalent.
Excellent leadership, communication, strategic thinking, project management, and stakeholder management skills.

Nice To Haves

Experience supporting late-stage clinical development and commercial products.
Knowledge of AI-enabled quality solutions, digital transformation, data analytics, and executive dashboard development.
Professional certification such as ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), RAC, or equivalent is preferred.
Demonstrated ability to lead global, cross-functional initiatives and build high-performing teams in a fast-paced, regulated environment.

Responsibilities

Lead the Global Quality Systems Monitoring & Excellence program to ensure effective governance, compliance, and continuous improvement across the Quality Management System (QMS).
Drive global audit and regulatory inspection readiness by leading inspection planning, mock inspections, execution support, response coordination, and post-inspection remediation.
Develop and monitor Quality KPIs/KQIs, analyze trends, identify systemic risks, and provide executive reporting through Quality Management Reviews (QMRs).
Perform Quality System health assessments and effectiveness reviews to identify compliance gaps and drive sustainable improvements.
Oversee CAPA governance related to internal audits & inspections, root cause analysis, effectiveness verification, and closure of audit and inspection commitments.
Lead the management of critical quality issues and escalations, facilitate timely cross-functional investigations and remediation plans, and ensure effective resolution of compliance risks and regulatory commitments.
Partner with cross-functional stakeholders to standardize, simplify, and optimize Quality processes while ensuring compliance with global GxP regulations.
Lead regulatory intelligence activities and translate evolving global regulatory expectations into Quality System enhancements.
Leverage AI, automation, data analytics, and digital Quality platforms to enhance compliance monitoring, executive reporting, and operational excellence.
Build and lead a high-performing team while fostering a culture of quality, compliance, inspection readiness, and continuous improvement across the organization.