Quality Specialist - GxP Electronic Systems

Revolution Medicines • Redwood City, CA

3h • Hybrid

About The Position

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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Provide Veeva Quality Platform business administration support, including configuration support, access management, and user assistance within validated GxP systems.
Provide administrative support for quality systems including ComplianceWire, Inspection Management Systems, and DocuSign by coordinating user provisioning, overseeing training records, generating reports, and maintaining system documentation.
Deliver instructor-led classroom training sessions for end users on Quality Platforms functionality and system workflows.
Develop and maintain system reports and interactive dashboards to track key performance indicators (KPIs) and operational metrics.
Support GxP training compliance by ensuring completeness and accuracy of training files, including CVs and job descriptions for GxP personnel.
Update and manage internal content on RevMed’s intranet site, contributing to clear and effective interdepartmental communications.
Execute and document test scripts for configuration changes to validated electronic systems, ensuring compliance with quality and regulatory requirements.
Support the development and distribution of information newsletters and communications related to Veeva system configuration updates.
Contribute to internal audit & inspection readiness by gathering records, generating reports, and ensuring document traceability within the electronic QMS.

Requirements

• Bachelor’s degree in Life Sciences or related field (advanced degree preferred)
• 1-2 years of experience in GxP Quality Assurance within the pharmaceutical, biotechnology, or related regulated industry.
• Demonstrate ability to manage multiple tasks, prioritize effectively, and meet deadlines.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
• Experience with electronic Quality Management Systems (eQMS) such as Veeva Quality Suite
• Ability to work independently and collaboratively across cross-functional teams in a dynamic environment

Nice To Haves

• Familiarity with Document Control, Training Compliance, Audit Management, GxP systems validation within a pharmaceutical quality system.
• Experience supporting change management in GxP systems.
• A continuous improvement mindset and willingness to take initiative in solving problems.

Responsibilities

• Provide Veeva Quality Platform business administration support, including configuration support, access management, and user assistance within validated GxP systems.
• Provide administrative support for quality systems including ComplianceWire, Inspection Management Systems, and DocuSign by coordinating user provisioning, overseeing training records, generating reports, and maintaining system documentation.
• Deliver instructor-led classroom training sessions for end users on Quality Platforms functionality and system workflows.
• Develop and maintain system reports and interactive dashboards to track key performance indicators (KPIs) and operational metrics.
• Support GxP training compliance by ensuring completeness and accuracy of training files, including CVs and job descriptions for GxP personnel.
• Update and manage internal content on RevMed’s intranet site, contributing to clear and effective interdepartmental communications.
• Execute and document test scripts for configuration changes to validated electronic systems, ensuring compliance with quality and regulatory requirements.
• Support the development and distribution of information newsletters and communications related to Veeva system configuration updates.
• Contribute to internal audit & inspection readiness by gathering records, generating reports, and ensuring document traceability within the electronic QMS.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level