Senior Manager, GxP Training

Posted 21 Days Ago
Be an Early Applicant
Redwood City, CA, USA
In-Office
164K-205K Annually
Senior level
Healthtech • Biotech
The Role
Lead the GxP training quality systems team, manage companywide GxP training programs, author SOPs/Work Instructions, monitor quality metrics, drive continuous improvement, support audits/inspections, and mentor staff to ensure regulatory compliance and operational effectiveness.
Summary Generated by Built In

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.

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.

#LI-Hybrid #LI-JC1

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

Please note that base pay salary range 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].

Base Pay Salary Range
$164,000$205,000 USD

We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
 
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
 
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.


Top Skills

Eqms
Qms)
Training
Veeva Qualitysuite (Qualitydocs
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The Company
Redwood City, California
548 Employees
Year Founded: 2014

What We Do

We are Revolutionaries – passionate in our singular pursuit of discovering, developing and delivering innovative, targeted medicines for patients living with cancer. To deliver on our vision, we work relentlessly in pursuit of cutting-edge therapeutic approaches to some of the toughest cancers. Our current focus is on RAS-addicted cancers, which account for 30 percent of all new human cancer diagnoses

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