Senior QA Manager, Quality Management System (QMS)

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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity: 

• Lead the quality system team responsible for GxP processes including document management, training management, deviation/investigation, CAPA/effectiveness checks, change control, product quality complaints and shipping issues/excursions 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.

• Review/approve document change controls (DCC) to ensure GxP procedural document changes and revisions are appropriately controlled.

• 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 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 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.

• Proficient with Microsoft Office including Word, Excel, PowerPoint experience with Project a plus.

• 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.

Preferred Skills:

• Strategic thinking and project management skills.

• Direct experience with handling and/or participating in regulatory body inspections.

The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected].

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