Senior Manager, GxP Training

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

In this role youll be a key contributor supporting multiple areas of RevMeds 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.

Required Skills Experience and Education:

• 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

Preferred Skills:

• 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.

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