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Form of workRevolution 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:
The Director of IT Quality is responsible for managing technical and operational components of the IT validation program focusing on GxP-regulated computerized systems, Computer System Validation/Computer Software Assurance (CSV/CSA) and the computerized system lifecycle ensuring compliance with regulatory requirements, policy, CSV procedures, and data integrity.
The role is hands-on, cross functional, and works closely with the QA, Clinical, Development and Technology groups. Incumbent is responsible for Computer System Validations in modern cloud-based environments with multiple SaaS and COTS systems. The ideal candidate will be able to lead and work with project coordinators and contract validation analysts/engineers to create product that is consistent with validation plans, SOPs, and modern risk-based approaches to CSV/CSA.
The incumbent will maintain the lifecycle of validation: IT change control, IT vendor assessments, perform periodic reviews and re-qualification, and maintain validated applications in a SaaS environment. Assist in creating, reviewing and editing SOPs and Work Instructions. Provide CSV subject matter expert support in audits (internal, external, vendor, regulatory agencies). Work closely with the QA and Regulatory functions to provide expertise in CSV compliance, manage identified issues, and support continuous improvement of the CSV program.
This position reports to the Senior Director, Information Sciences and can be a remote role or a hybrid role based in Redwood City, CA.
Required Experience, Skills, and Education:
8+ years direct experience working in the life sciences/biotech/pharmaceutical industry in Quality, Compliance or Computer System Validation in a GxP-regulated environment or direct hands-on experience implementing and supporting CSV activities for clinical, regulatory and quality SaaS computerized systems and infrastructure.
Experience in the creation and maintenance of SOPs, Work Instructions, policy documents and related quality documentation.
Direct experience with validating SaaS COTS applications, IT vendor audits, SOWs, MSAs, quality agreements and cloud-based infrastructure.
Comprehensive knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP 5 requirements and FDA industry regulations.
Experience generating or leading the development of validation artifacts for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specifications, System Risk Classifications, Risk Assessments, IQ/OQs, UATs, Traceability Matrices, Validation Reports, and Change Controls ensuring documentation meets regulatory and procedural requirements.
Experience developing and leading CSV and lifecycle management activities; understanding of modern risk-based validation.
Excellent technical writing, project management, and organizational skills.
Knowledge of GDPR, HIPAA and data privacy directives is preferred.
Some travel may be required for on-site vendor audits.
Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company's offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.
The expected salary range for this role is $210,000 to $240,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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.
