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 and computer system validation (CSV) background to play a critical role as Senior Manager, IS Quality and Compliance in the Information Sciences Department (IS). This hand-on role is responsible for ensuring the GxP compliance for all internal computerized systems used at RevMed and for supporting the IT third-party vendor management program. This position reports to the Director IS Quality, Risk, and Compliance.

Required Skills, Experience and Education:

• Provide project and CSV leadership for GxP computerized systems to ensure the development and implementation of validation strategies and deliverables that meet regulatory requirements and industry standards.
• Collaborate with IS, vendors, System/Business Owners, and Quality to ensure that CSV activities are planned and executed in accordance with 21 CFR Part 11, Annex 11, GAMP 5, and internal procedures.
• Provide oversight for the CSV program including writing, reviewing, executing, and approving System Risk Classifications, ERES Assessments, URS, FRS, Configuration Specifications, Validation Plans, Risk Assessments, Test Protocols and Reports, Traceability Matrices, Data Migration Plans, and other validation deliverables.
• Author and revise CSV procedures, forms, and templates for continuous improvement.
• Collaborate with System/Business Owners and Quality to assess and classify computerized systems for regulatory impact (GxP, SOX, HIPAA, Privacy, PCI) and coordinate with compliance teams to ensure effective controls.
• Own CSV-related incidents, deviations and CAPAs, managing remediation efforts.
• Perform CSV inspection readiness preparations and/or directly support regulatory agency audit and inspections. Assist in the coordination of response to any findings as applicable.
• Manage change control activities for GxP computerized systems.
• Own and maintain the IS Quality System Inventory Listing.
• Perform periodic review analysis of validation documentation, systems, vendors, and practices.
• Communicate identified gaps, including recommending and implementing corrective actions and improvements.
• Serve as IS subject matter expert (SME) regarding Data Integrity and CSV lifecycle.
• Execute data integrity assessments, access control, and audit trail reviews partnering with IS, System/Business Owners, and Quality to ensure effective controls.
• Partner with IS, System/Business Owners, and Quality to complete vendor assessments and qualification activities for software and service providers who process data on our behalf.
• Manage and oversee third-party vendor security assessments as an administrator of the electronic vendor risk management platform.
• Partner with IS, System/Business Owners, Quality, and auditors to mitigate and remediate risks for critical suppliers.
• Minimum bachelor’s degree in science or IT related discipline.
• Minimum 10 years professional and management experience in GxP regulated environment.
• Minimum 10 years Computer System Validation experience in the pharmaceutical/ biopharma space.
• Working knowledge of GxP regulations, CSV/CSA principles, 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.

• Maintains awareness of current and upcoming FDA Computer Software Assurance (CSA) principles.
• Ability to lead and manage multiple CSV projects for complex computer systems.
• Understanding of CSV expectations for cloud-based/SaaS systems.
• Experience performing third-party vendor audits with focus on security, privacy, and data governance.
• 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).
• Results-oriented with the capacity to execute projects with minimal supervision.
• Attention to detail and quality.

Preferred Skills:

• Direct experience with electronic signature and document management systems such as DocuSign Part 11, Veeva QualityDocs, Egnyte GXP.
• Familiarity with Quality, Regulatory, and Clinical Data Management platforms such as Veeva QMS, Medidata Rave, IQVIA RIMSmart.
• Experience with vendor management platforms such as OneTrust, Black Kite, Viso Trust.
• Pharma/Biotech Commercial experience a plus.
• Experience working with artificial intelligence (AI) tools.