Senior Manager, GxP Training

Revolution Medicines • Redwood City, CA

18h • 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:
In this role, you'll be a key contributor, supporting multiple areas of RevMed’s Quality Management System (QMS) and ensuring our compliance efforts are successful.
Lead the quality system team responsible for GxP training management including continuous improvement implementations that meet business and regulatory requirements.
Partner with key stakeholders to proactively evaluate and monitor the health of the quality systems. Drive improvements to enhance operational effectiveness and address compliance risks.
Oversight for companywide GxP training programs, ensuring training requirements to specific GxP job functions aligned to job descriptions.
Ensure that training and continuing external education programs are appropriately implemented, reviewed, technically sound, and aligned with current GxP requirements.
Analyze quality data and continuously monitor metrics to assess performance, recommend process improvements or preventive actions.
Develop and implement ways to improve Quality Systems business processes and strategies, which increase efficiency, improve compliance, and reduce system maintenance requirements.
Create and Implement quality systems business processes and author SOPs and Work Instructions for eQMS training management systems.
Provide support during internal audits and regulatory body inspections, including managing and coordinating all inspection logistics.
Provide leadership, mentorship, and coaching to the Quality System GxP Training team, fostering a culture of quality excellence, accountability, and continuous learning.

Requirements

• BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
• Minimum 10 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).
• 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

• Lead the quality system team responsible for GxP training management including continuous improvement implementations that meet business and regulatory requirements.
• Partner with key stakeholders to proactively evaluate and monitor the health of the quality systems. Drive improvements to enhance operational effectiveness and address compliance risks.
• Oversight for companywide GxP training programs, ensuring training requirements to specific GxP job functions aligned to job descriptions.
• Ensure that training and continuing external education programs are appropriately implemented, reviewed, technically sound, and aligned with current GxP requirements.
• Analyze quality data and continuously monitor metrics to assess performance, recommend process improvements or preventive actions.
• Develop and implement ways to improve Quality Systems business processes and strategies, which increase efficiency, improve compliance, and reduce system maintenance requirements.
• Create and Implement quality systems business processes and author SOPs and Work Instructions for eQMS training management systems.
• Provide support during internal audits and regulatory body inspections, including managing and coordinating all inspection logistics.
• Provide leadership, mentorship, and coaching to the Quality System GxP Training team, fostering a culture of quality excellence, accountability, and continuous learning.

What This Job Offers

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