Job Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. 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.
Opportunity:
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Responsible for overseeing and executing critical quality system processes such as Change Controls, Deviations, CAPAs/Effectiveness checks, Product Complaints, and Shipping Excursions supporting both clinical and commercial product lifecycles.
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Own and manage change control program for clinical and commercial products changes. Ensure proper cross-functional impact assessment, change categorization, implementation plans, approvals and timely closure.
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Serve as QA lead for intake, triage, and investigation of product quality complaints from clinical sites, patients, or commercial partners. Coordinate with manufacturing/packaging sites, CROs, and 3PLs/Depots to ensure complaint investigations are thorough, compliant, and resolved in a timely manner.
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Lead evaluation and approval of shipping/temperature excursions across clinical and commercial shipments, warehouses, and site storage.
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Escalate critical issues and quality risks to senior leadership with adequate risk impact and recommendations.
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Oversee internal/external deviations and investigations from initial assessment, escalation, root cause analysis, QA impact assessment, approval and closure.
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Lead initiation, implementation, tracking, and verification of CAPAs/Effectiveness Checks linked to deviations, product complaints and shipping/temperature excursions.
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Review, monitor and trend external partner quality event records, ensuring sponsor oversight and accountability for third-party operations.
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Partner with key internal stakeholders to proactively evaluate and monitor the health of the quality systems. Drive improvements to enhance operational effectiveness, and address compliance risks.
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Analyze quality data and continuously monitor metrics to assess system performance. Support preparation of slides and content for Quality Management Review (QMR) and leadership updates.
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Create and Implement quality systems business processes and author SOPs and Work Instructions for eQMS systems.
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Provide support as key SME during internal audits and regulatory body inspections, including managing and coordinating inspection logistics.
Required Skills, Experience and Education:
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BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
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Minimum 10 years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment.
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Direct experience with quality events deviation, CAPA, change control, complaint, and temperature excursion processes are essential.
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Experience managing GxP quality events across external partners (CMOs, CROs, 3PLs).
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Expertise in investigation writing, decision making, and cross-functional collaboration.
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Strong communication, quality mindset, and leadership in a matrixed or virtual sponsor environment.
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Experience in developing and implementing GxP quality system business processes to meet current regulatory and industry standards.
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Excellent working knowledge and understanding of GxP requirements, proficiency in applying regulatory requirements and ICH guidelines.
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Direct experience working with Veeva QualitySuite electronic platforms (QualityDocs, Training, QMS).
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Excellent communication skills, both oral and written to clearly and concisely communicate with internal and external team members.
Preferred Skills:
The base salary range for this full-time position is $180,000 to $225,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary 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 privacy@revmed.com
