Senior Manager, GMP Quality

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.

The Opportunity: 

Revolution Medicines is seeking a motivated individual with a pharmaceutical quality assurance background to play a   critical role as QA Documentation Specialist and provides quality oversight on processing of all internal & external GxP documentation at RevMed. This position is reported to the Manager of GxP Documentation and Training

Revolution Medicines is seeking a Senior Manager, GMP Quality, who will play a key role within Quality Assurance and is responsible for providing leadership and QA operational support for RevMed programs through different phases of development (Phase II to commercial), with a strong emphasis on late-stage drug product development, process validation, inspection readiness and product launch. The candidate will act as the QA lead for a late phase project and independently manage all the QA responsibilities with minimum supervision.

• Responsible for providing QA support for batch disposition, quality record ownership, and management of QA activities for clinical and commercial products.

• Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices.

• Collaborate with internal and external stakeholders and execute quality systems such as the QA SME on deviation investigations, CAPA plans, change controls, shelf-life extensions, revisions to documentation, and other Quality processes.

• Lead efforts for QA oversight of the manufacture, validation, and disposition of pre-clinical, clinical, and commercial product materials, including drug substance (DS), drug product (DP), and final product (FP) at CMOs in partnership with PDM (CMC), Supply Chain, Analytical Development, and other functions.

• Support late-stage drug product validation (PPQ) activities and ensure compliance with regulatory expectations for commercial readiness.

• Establish and maintain internal quality metrics for the GMP Quality group that predict the performance and health of the quality systems and processes and effectively communicate compliance-related metrics, risks, and compliance challenges to senior management.

• Provide Quality oversight as well as review and approval of CMO documentation (e.g., specification documents, Method Validations, Stability records, Master Batch records, label proofs, etc.) as well as review executed batch records, applicable test data (in-process and release), and product dispositions.

• QA lead in periodically reviewing and revising GMP-related SOPs and procedures.

• Support quality review of regulatory documents (IND/IMPD, NDA) to ensure compliance with late-stage and commercial drug product validation requirements.

• Participate in inspection readiness efforts, particularly for late-stage development and commercial launch preparations.

• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Required Experience, Skills, and Education:

• A bachelor’s degree in a scientific or technical discipline is required.

• A minimum of 10-12 years of experience in GMP Quality in the pharmaceutical industry, with at least 5+ years on experience in managing late-stage drug product development (solids), validation, and product launch.

• Experience managing quality aspects of development, validation, manufacturing, and testing activities at CMOs, particularly for late-stage drug product process validation and commercialization.

• Experience in process validation (PPQ), late-stage regulatory submissions, and commercial readiness.

• Experience in Inspection Readiness (domestic and ex-US).

• Excellent analytical skills and a strong technical background in small molecule process development, validation, and testing are strongly desired.

• Knowledge of applicable US FDA (i.e., 21 CFR 210, 211, 312, Part 11) and Global compliance regulations (ICH, EU directives) and best industry practices (CGMPs).

• Ability to critically evaluate and troubleshoot complex problems with diligence.

• Strong teamwork, collaboration, and management skills.

• Ability to manage multiple priorities and aggressive timelines.

• Highly responsible, self-motivated professional with enthusiasm and passion for work.

• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Preferred Skills:

• Hands-on experience working in a manufacturing environment overseeing QA responsibilities for commercial and late-stage clinical assets (Phase) is preferred.

The base salary range for this full-time position is $158,000 to $198,000 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 [email protected].

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