Senior Manager, Quality Systems Deviation, CAPA, CC

Redwood City, CA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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:

Provide day-to-day oversight and management for Change Control Deviations and Corrective and Preventive Action (CAPA) programs ensuring effective execution compliance and continuous monitoring including improvement of these processes within the Quality Management System (QMS).
Lead or facilitate quality governance forums (e.g. Change Control Review Boards Deviation/CAPA Review Boards) using risk-based science-driven decision-making.
Ensure timely initiation investigation root cause analysis and closure of deviations and CAPAs in alignment with regulatory expectations and internal quality standards.
Collaborate cross-functionally with Regulatory CMC Analytical Development / Quality Control Drug Substance Drug Product Supply Chain Clinical Functions and external partners to ensure effective assessment and implementation of changes and CAPAs.
Design maintain and continuously improve integrated processes for change management and deviation management including SOPs work instructions templates training materials and workflows.
Develop and deliver training programs and provide subject matter expertise to drive consistent application of quality processes across internal teams and external partners.
Establish and maintain dashboards KPIs and trend analyses to monitor process performance compliance and effectiveness.
Support management review activities by providing integrated quality metrics trend analyses and insights.
Support the overall QMS framework to ensure compliance with FDA EMA ICH and other global regulatory requirements.
Serve as a subject matter expert during internal audits external audits and regulatory inspections related to change management and deviation/CAPA management processes.

Required Skills Experience and Education:

Bachelors degree in Science Engineering Computer Systems or related field (advanced degree preferred).
Minimum 810 years of experience in Quality Systems within the pharmaceutical or biotechnology industry.
Demonstrated expertise in Change Control Deviations and CAPA management including use of electronic QMS tools (preferably Veeva Quality Vault QMS).
Excellent analytical root cause analysis and problem-solving capabilities.
Ability to influence and collaborate effectively across functions and organizational levels.
Strong understanding of GxP regulations FDA and EMA expectations and ICH Q10 principles.
Experience supporting late-stage development and/or commercial products in an outsourced manufacturing and testing model.

Preferred Skills:

Experience leading governance forums and driving continuous improvement initiatives.
Detail-oriented with the ability to balance compliance efficiency and business needs.
#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 ourCCPA additional information please contact .

Base Pay Salary Range

$164000$205000 USD

Required Experience:

Senior Manager