Quality Assurance Manager, GxP Electronic Systems

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 Manager, GxP Electronic Systems and provides quality oversight and ensures GxP compliance for all internal & external computerized systems used at RevMed. This position reports to the Senior Manager, QA Compliance.

• Provide quality oversight for the Computer System Validation (CSV) program, including the review and approval of System Risk Classifications, Validation Plans, Risk Assessments, Test Protocols and Reports, Traceability Matrices, and other validation execution deliverables.
• QA Review and approval of computer system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements.
• Act as a business admin and ensures that all the electronic Quality Management Systems owned by QA is maintained in accordance with current regulatory compliance requirements and meets company objectives
• Ensure the execution of data integrity assessments, access controls and partner with System & Business Owners for effective controls.
• Serve as the QA subject matter expert (SME) regarding Data Integrity and CSV lifecycle.
• Support the development and continuous improvement of the Quality Management System (QMS)
• Review and approve CSV-related incidents, deviations and CAPAs, managing remediation efforts.
• Review and approve change control activities for the computerized systems.
• Support GxP computer system audits and ensure QA qualification of computer system vendors.
• Partner with Information Science and external vendors in the validation and delivery of new GxP systems.
• Provide ongoing Quality support, advice, and guidance to GXP related System Owners and System Administrators.
• Provide QA guidance in the development and revision of GXP computer system procedures.
• Support regulatory audits and inspections.
  
  

Required Skills, Experience and Education:

• Minimum bachelor’s degree in engineering or life science related field.
• Minimum 5-7 years in Quality Systems 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.
• Knowledge of Quality Risk Management per ICH Q9.
• Maintains awareness of current and upcoming FDA Computer Software Assurance (CSA) principles
• Familiarity with Quality, Regulatory, and Clinical Data Management platforms such as Veeva.
• Results-oriented with the capacity to execute projects with minimal supervision.
• Proficiency in Microsoft Office, including process mapping/project management tools.
  
  

Preferred Skills:

• Direct experience with Veeva Quality Vault eDMS/eQMS/eLMS
• Pharma/Biotech Commecial experience a plus.
• Previous managerial experience
  
  

The expected salary range for this role is $120,000 to $158,000. 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.

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