Revolution Medicines

Revolution Medicines

Senior Manager IS Quality and Compliance

Redwood City, California, United States · Senior · Full-time

Sponsorship not specified$164k-$205kDetected 1 day ago
ComplianceSupply ChainERPHIPAAFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingMentoringNetSuiteGxP

About the role

  • 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.
  • 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.
  • 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.
  • Lead cross-functional initiatives to advance Computer Software Assurance (CSA), enhance risk-based validation practices, and continuously improve the GxP computerized system lifecycle.
  • Maintain the IS Quality System Inventory while developing quality metrics, trend analyses, and continuous improvement initiatives to strengthen the computerized system compliance program.
  • Demonstrated ability to lead multiple complex validation projects simultaneously.
  • Experience supporting enterprise GxP applications (e.g., Quality, Regulatory, Clinical, Supply Chain, ERP, and Document Management systems such as Veeva, DocuBridge, Trial Interactive eTMF, NetSuite, TraceLink, etc.)

Requirements

  • Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, or related discipline.
  • Minimum 10 years of experience supporting GxP computerized systems in the pharmaceutical or biotechnology industry.
  • Experience with cloud-based/SaaS GxP applications and risk-based validation approaches.

Nice to have

  • Preferred Skills:

Skills

  • Experience supporting AI-enabled or emerging digital technologies in regulated environments.
  • Knowledge of IT security frameworks such as NIST, ISO/IEC 27001, SOC 2.
  • Familiarity with privacy and financial regulations such as GDPR, HIPAA, Sarbanes-Osley (SOX).
  • Commercial pharmaceutical or biotechnology experience.
  • #LI-YG1 #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.
  • For additional information, please contact privacy@revmed.com.
  • Base Pay Salary Range
  • $164,000 - $205,000 USD
  • All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.

Compensation

  • $164,000 - $205,000 USD
  • 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.

Benefits

  • Required Skills, Experience and Education

Company info

  • 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.
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This listing is sourced directly from Revolution Medicines's careers page and normalized into a canonical job model.