Senior Manager, Quality Systems - Deviation, CAPA, CC
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:
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.
Responsibilities
• 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.
Requirements
• Bachelor’s degree in Science, Engineering, Computer Systems, or related field (advanced degree preferred).
• Minimum 8–10 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.
Nice-to-haves
• Experience leading governance forums and driving continuous improvement initiatives.
• Detail-oriented with the ability to balance compliance, efficiency, and business needs.
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Apply To this Job
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:
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.
Responsibilities
• 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.
Requirements
• Bachelor’s degree in Science, Engineering, Computer Systems, or related field (advanced degree preferred).
• Minimum 8–10 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.
Nice-to-haves
• Experience leading governance forums and driving continuous improvement initiatives.
• Detail-oriented with the ability to balance compliance, efficiency, and business needs.
Apply tot his job
Apply To this Job