About this Associate Director, Quality Systems Monitoring & Excellence role at Revolution 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:
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Lead the Global Quality Systems Monitoring & Excellence program to ensure effective governance, compliance, and continuous improvement across the Quality Management System (QMS).
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Drive global audit and regulatory inspection readiness by leading inspection planning, mock inspections, execution support, response coordination, and post-inspection remediation.
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Develop and monitor Quality KPIs/KQIs, analyze trends, identify systemic risks, and provide executive reporting through Quality Management Reviews (QMRs).
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Perform Quality System health assessments and effectiveness reviews to identify compliance gaps and drive sustainable improvements.
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Oversee CAPA governance related to internal audits & inspections, root cause analysis, effectiveness verification, and closure of audit and inspection commitments.
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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.
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Partner with cross-functional stakeholders to standardize, simplify, and optimize Quality processes while ensuring compliance with global GxP regulations.
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Lead regulatory intelligence activities and translate evolving global regulatory expectations into Quality System enhancements.
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Leverage AI, automation, data analytics, and digital Quality platforms to enhance compliance monitoring, executive reporting, and operational excellence.
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Build and lead a high-performing team while fostering a culture of quality, compliance, inspection readiness, and continuous improvement across the organization.
Required Skills, Experience and Education:
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Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or a related scientific discipline; Master's degree preferred.
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10+ years of progressive Quality Assurance/Quality Systems experience in the biotechnology, pharmaceutical, or medical device industry, including people leadership.
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Strong knowledge of global GxP regulations, including FDA, EMA, ICH, and applicable international quality standards.
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Demonstrated experience leading regulatory inspections, internal audits, Quality Management Reviews (QMRs), and Quality Systems governance.
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Experience with electronic Quality Management Systems (eQMS), such as Veeva Vault or equivalent.
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Excellent leadership, communication, strategic thinking, project management, and stakeholder management skills.
Preferred Skills:
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Experience supporting late-stage clinical development and commercial products.
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Knowledge of AI-enabled quality solutions, digital transformation, data analytics, and executive dashboard development.
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Professional certification such as ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), RAC, or equivalent is preferred.
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Demonstrated ability to lead global, cross-functional initiatives and build high-performing teams in a fast-paced, regulated environment.
#LI-JC1 #LI-Hybrid
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.
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.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected].
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.
