Senior Manager, GxP Electronic System Validation QA

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The companys 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:

• Serve as the Computer System Validation (CSV) QA subject matter expert and provide guidance on the interpretation and application of global GxP regulations and guidance related to computerized systems electronic records electronic signatures and data integrity including FDA 21 CFR Part 11 EU Annex 11 and GAMP principles.

• Provide Quality Assurance oversight of CSV activities for internal and external GxP computerized systems ensuring validation activities are conducted in compliance with regulatory requirements and company Software Development Life Cycle (SDLC) standards.

• Implement and promote best practices for data governance and data integrity ensuring computerized systems meet GxP compliance requirements throughout their lifecycle.

• Lead and provide oversight for Data Integrity and Computer System Validation programs and activities.

• Review and approve CSV documentation including validation plans requirements risk assessments test protocols validation reports and system retirement documentation.

• Review and approve GxP change controls deviations CAPAs and other quality records to ensure compliance with quality and regulatory requirements.

• Lead supplier audits assessments qualification and requalification activities for electronic system vendors and service providers.

• Support the development implementation and continuous improvement of computerized system policies procedures validation methodologies and quality processes.

• Collaborate cross-functionally to identify compliance risks process gaps and opportunities for improvement and drive implementation of effective solutions.

• Provide guidance education and training to cross-functional teams on risk-based validation approaches and GxP system deployment.

• Support inspection readiness initiatives and represent Quality Assurance during partner audits customer audits and regulatory inspections.

• Monitor evolving regulatory expectations and industry trends related to computerized systems validation data integrity and digital quality systems.

Required Skills Experience and Education:

• Bachelors degree in computer science Information Systems Engineering Life Sciences or a related discipline or equivalent combination of education and experience.

• Minimum 8 years of Quality Assurance experience in the pharmaceutical biotechnology or life sciences industry supporting GxP computerized systems.

• Extensive experience in Computerized Systems Validation (CSV) and/or Computer Software Assurance (CSA) with strong knowledge of GAMP 5 SDLC and risk-based validation methodologies.

• Expert knowledge of FDA 21 CFR Part 11 EU Annex 11 Data Integrity and ALCOA principles including electronic records and electronic signatures compliance requirements.

• Broad experience with GxP computerized systems and the ability to author review and approve validation deliverables risk assessments testing documentation and compliance-related records throughout the system lifecycle.

Preferred Skills:

• Experience supporting regulatory inspections internal audits and supplier/vendor audits.

• Familiarity with cloud-based/SaaS platforms vendor qualification and third-party risk management.

• Excellent analytical problem-solving and cross-functional collaboration skills.

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