Senior QA Specialist, Quality Systems, GxP Training

Revolution Medicines•Redwood City, CA

15h•$90,000 - $108,000•Hybrid

About The Position

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s 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: Support the continuous enhancement of the GxP Training Program within the Quality Systems function, ensuring training processes, curricula, and learning strategies meet business objectives and global regulatory requirements. Serve as the Quality Systems subject matter expert for GxP training, partnering cross-functionally with stakeholders to assess training needs, evaluate program effectiveness, and drive continuous improvement initiatives that strengthen compliance and operational excellence. Design, develop, and maintain the instructor-led and web-based GxP training curricula using GxP learning principles and instructional design methodologies to support onboarding, role-based qualification, and continuing education programs. Collaborate with functional leaders and SMEs to create engaging classroom training materials, eLearning content, facilitator guides, assessments, and blended learning solutions aligned with GxP requirements and job-specific competencies. Execution and administration of companywide GxP training programs, ensuring training assignments, curricula, and qualification requirements are aligned with job descriptions, procedural changes, and regulatory expectations. Evaluate the effectiveness of training programs through metrics, learner feedback, compliance trends, and quality data analysis; recommend and implement improvements to enhance learning outcomes and inspection readiness. Develop and implement scalable Quality Systems processes, strategies, SOPs, and Work Instructions related to GxP training management and electronic Quality Management Systems (eQMS). Drive a culture of quality, compliance, and continuous learning by influencing stakeholders, facilitating knowledge sharing, and promoting best practices in training and instructional design across the organization. Support cross-functional initiatives related to training process optimization, learning technologies, and quality system improvements without direct people management responsibilities.

Requirements

BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
Minimum 5+ years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment.
Experience in developing and implementing GxP quality systems to meet current regulatory and industry standards.
Direct experience managing GxP document management and training systems.
Excellent working knowledge and understanding of GxP requirements, proficiency in applying regulatory requirements and ICH guidelines.
Direct experience working with Veeva QualitySuite electronic platforms (QualityDocs, Training, QMS).
Proficient with Microsoft Office including Word, Excel, PowerPoint experience is a plus.
Excellent communication skills, both oral and written to clearly and concisely communicate with internal and external team members.
Ability to work independently and collaboratively across cross-functional teams in a dynamic environment.

Nice To Haves

Strategic thinking and project management skills.
Direct experience with handling and/or participating in regulatory body inspections.
A continuous improvement mindset and willingness to take initiative in solving problems.
Experience in both virtual sponsor and scaling global organization models.

Responsibilities

Support the continuous enhancement of the GxP Training Program within the Quality Systems function, ensuring training processes, curricula, and learning strategies meet business objectives and global regulatory requirements.
Serve as the Quality Systems subject matter expert for GxP training, partnering cross-functionally with stakeholders to assess training needs, evaluate program effectiveness, and drive continuous improvement initiatives that strengthen compliance and operational excellence.
Design, develop, and maintain the instructor-led and web-based GxP training curricula using GxP learning principles and instructional design methodologies to support onboarding, role-based qualification, and continuing education programs.
Collaborate with functional leaders and SMEs to create engaging classroom training materials, eLearning content, facilitator guides, assessments, and blended learning solutions aligned with GxP requirements and job-specific competencies.
Execution and administration of companywide GxP training programs, ensuring training assignments, curricula, and qualification requirements are aligned with job descriptions, procedural changes, and regulatory expectations.
Evaluate the effectiveness of training programs through metrics, learner feedback, compliance trends, and quality data analysis; recommend and implement improvements to enhance learning outcomes and inspection readiness.
Develop and implement scalable Quality Systems processes, strategies, SOPs, and Work Instructions related to GxP training management and electronic Quality Management Systems (eQMS).
Drive a culture of quality, compliance, and continuous learning by influencing stakeholders, facilitating knowledge sharing, and promoting best practices in training and instructional design across the organization.
Support cross-functional initiatives related to training process optimization, learning technologies, and quality system improvements without direct people management responsibilities.