Senior Manager IS Quality and Compliance
Revolution Medicines
| Company | Revolution Medicines |
| Category | Operations & Admin |
| Location | Redwood City |
| Remote | On-site (inferred) |
| Employment | Not stated |
| Level | Manager |
| Salary | Not stated by the employer |
| Posted | 9 Jul 2026 |
| Last verified | 9 Aug 2026 |
| Source | Employer ATS (greenhouse) |
Description
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:
Revolution Medicines is seeking a motivated individual with a pharmaceutical quality assurance and computer system validation (CSV) background to play a critical role as Senior Manager, IS Quality and Compliance within the Information Sciences (IS) organization. This hands-on leadership role is responsible for providing technical leadership for GxP computerized system compliance across the Information Sciences organization by advancing risk-based Computer Software Assurance (CSA) practices, leading validation activities throughout the system lifecycle, and partnering with Quality and business stakeholders to maintain inspection readiness and regulatory compliance. This position reports to the Sr. Director, IS Quality, Risk & Compliance.
Responsibilities:
Act as the Information Sciences (IS) technical lead for Computer System Validation and Computer Software Assurance, providing expert guidance on computerized system compliance across the enterprise.
Provide technical leadership for Computer System Validation (CSV) and Computer Software Assurance (CSA) activities across GxP computerized systems, ensuring validation strategies align with regulatory requirements, business objectives, and industry best practices.
Provide guidance on the interpretation and practical application of GxP regulations and industry standards related to computerized systems, electronic records, electronic signatures, and data integrity.
Provide strategic guidance to project teams on validation approaches, system implementation strategies, and lifecycle compliance to ensure consistent application of risk-based validation principles.
Provide technical leadership and mentoring to project teams on CSV, CSA, and GxP computerized system compliance.
Partner with Information Sciences (IS), System Owners, Business Owners, and Quality to develop validation strategies, assess compliance requirements, and ensure validation activities are planned and executed in accordance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSA principles, and internal procedures.
Lead the development, review, and approval of validation lifecycle deliverables, including validation plans, risk assessments, requirements, testing documentation, traceability, reports, data migration, and system retirement documentation.
Author and continuously improve CSV procedures, templates, and lifecycle methodologies to support efficient, risk-based validation practices.
Partner with Quality, System Owners, Business Process Owners, and System Administrators to assess computerized systems for GxP impact and ensure appropriate validation and compliance controls are implemented.
Lead CSV-related deviations, investigations, CAPAs, change controls, and periodic reviews for assigned GxP systems.
Serve as the primary IS subject matter expert for CSV, CSA, Data Integrity, electronic records and signatures (21 CFR Part 11), and computerized system lifecycle compliance.
Conduct data integrity assessments, audit trail reviews, and access control reviews to ensure compliance with ALCOA+ principles and regulatory expectations.
Lead cross-functional initiative