Associate Director, Quality Systems & Compliance (GCP/GLP/GVP)
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:
Lead the development, implementation, and ongoing monitoring of GCP, GVP, and GLP quality metrics to evaluate the effectiveness, performance, and compliance of quality systems and compliance activities.
Act as the Veeva QMS system facilitator for all GCP, GLP, and GVP related quality events, documents, and records, ensuring effective governance, lifecycle management, data integrity and inspection readiness across quality management systems.
Partner with clinical quality team & internal stakeholders for timely closure of all GCP, GVP and GLP related quality issues and investigations, including deviations, CAPAs, serious breaches, protocol deviations, internal & external audit findings, and inspection observations, ensuring appropriate root cause analysis, corrective actions, and effectiveness checks.
Establish and maintain Key Quality Indicators (KQIs) and Key Performance Indicators (KPIs) and continuously improve Quality Systems supporting GCP, GVP, and GLP activities in alignment with FDA, EMA, ICH, and other global regulatory requirements.
Provide QA oversight and monitoring of computerized systems supporting clinical trials, pharmacovigilance, and nonclinical studies (e.g., EDC, CTMS, eTMF, Safety Systems), ensuring compliance with validation lifecycle requirements, 21 CFR Part 11, EU Annex 11, and applicable CSV & CSA standards.
Design and maintain quality metrics dashboards, trend analyses, and periodic executive-level reports for Quality Leadership and Quality Management Review (QMR) to enable risk-based decision-making and process improvement.
Facilitate and monitor internal procedural & training controls across GCP, GLP, and GVP activities to ensure alignment with regulatory requirements and quality system standards.
Serve as QA Subject Matter Expert (SME) for Quality Systems and Computerized System Validation, providing strategic guidance, technical expertise, and cross-functional leadership to ensure regulatory compliance, inspection readiness, and operational excellence.
Responsibilities
• Lead the development, implementation, and ongoing monitoring of GCP, GVP, and GLP quality metrics to evaluate the effectiveness, performance, and compliance of quality systems and compliance activities.
• Act as the Veeva QMS system facilitator for all GCP, GLP, and GVP related quality events, documents, and records, ensuring effective governance, lifecycle management, data integrity and inspection readiness across quality management systems.
• Partner with clinical quality team & internal stakeholders for timely closure of all GCP, GVP and GLP related quality issues and investigations, including deviations, CAPAs, serious breaches, protocol deviations, internal & external audit findings, and inspection observations, ensuring appropriate root cause analysis, corrective actions, and effectiveness checks.
• Establish and maintain Key Quality Indicators (KQIs) and Key Performance Indicators (KPIs) and continuously improve Quality Systems supporting GCP, GVP, and GLP activities in alignment with FDA, EMA, ICH, and other global regulatory requirements.
• Provide QA oversight and monitoring of computerized systems supporting clinical trials, pharmacovigilance, and nonclinical studies (e.g., EDC, CTMS, eTMF, Safety Systems), ensuring compliance with validation lifecycle requirements, 21 CFR Part 11, EU Annex 11, and applicable CSV & CSA standards.
• Design and maintain quality metrics dashboards, trend analyses, and periodic executive-level reports for Quality Leadership and Quality Management Review (QMR) to enable risk-based decision-making and process improvement.
• Facilitate and monitor internal procedural & training controls across GCP, GLP, and GVP activities to ensure alignment with regulatory requirements and quality system standards.
• Serve as QA Subject Matter Expert (SME) for Quality Systems and Computerized System Validation, providing strategic guidance, technical expertise, and cross-functional leadership to ensure regulatory compliance, inspection readiness, and operational excellence.
Requirements
• Bachelor’s degree in Life Sciences or related field (advanced degree preferred).
• Minimum 10+ years of experience in GxP Quality Assurance within the pharmaceutical, biotechnology, or related regulated industry.
• Minimum 5+ years supporting GCP, GVP, and/or GLP quality systems and compliance areas
• Strong experience developing, monitoring, and reporting quality metrics.
• Experience with QA oversight of computerized system validation (CSV) for clinical and safety systems.
• Experience supporting regulatory inspections and audits (FDA, EMA, MHRA, or other global regulatory bodies).
Nice-to-haves
• Strong analytical skills with ability to interpret quality metrics and identify trends and risks.
• Excellent communication and presentation skills, with ability to present to senior leadership.
• Strong leadership, problem-solving, and organizational skills.
• Ability to work effectively in a fast-paced, cross-functional, and regulated environment.
Apply Now
Apply Now
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:
Lead the development, implementation, and ongoing monitoring of GCP, GVP, and GLP quality metrics to evaluate the effectiveness, performance, and compliance of quality systems and compliance activities.
Act as the Veeva QMS system facilitator for all GCP, GLP, and GVP related quality events, documents, and records, ensuring effective governance, lifecycle management, data integrity and inspection readiness across quality management systems.
Partner with clinical quality team & internal stakeholders for timely closure of all GCP, GVP and GLP related quality issues and investigations, including deviations, CAPAs, serious breaches, protocol deviations, internal & external audit findings, and inspection observations, ensuring appropriate root cause analysis, corrective actions, and effectiveness checks.
Establish and maintain Key Quality Indicators (KQIs) and Key Performance Indicators (KPIs) and continuously improve Quality Systems supporting GCP, GVP, and GLP activities in alignment with FDA, EMA, ICH, and other global regulatory requirements.
Provide QA oversight and monitoring of computerized systems supporting clinical trials, pharmacovigilance, and nonclinical studies (e.g., EDC, CTMS, eTMF, Safety Systems), ensuring compliance with validation lifecycle requirements, 21 CFR Part 11, EU Annex 11, and applicable CSV & CSA standards.
Design and maintain quality metrics dashboards, trend analyses, and periodic executive-level reports for Quality Leadership and Quality Management Review (QMR) to enable risk-based decision-making and process improvement.
Facilitate and monitor internal procedural & training controls across GCP, GLP, and GVP activities to ensure alignment with regulatory requirements and quality system standards.
Serve as QA Subject Matter Expert (SME) for Quality Systems and Computerized System Validation, providing strategic guidance, technical expertise, and cross-functional leadership to ensure regulatory compliance, inspection readiness, and operational excellence.
Responsibilities
• Lead the development, implementation, and ongoing monitoring of GCP, GVP, and GLP quality metrics to evaluate the effectiveness, performance, and compliance of quality systems and compliance activities.
• Act as the Veeva QMS system facilitator for all GCP, GLP, and GVP related quality events, documents, and records, ensuring effective governance, lifecycle management, data integrity and inspection readiness across quality management systems.
• Partner with clinical quality team & internal stakeholders for timely closure of all GCP, GVP and GLP related quality issues and investigations, including deviations, CAPAs, serious breaches, protocol deviations, internal & external audit findings, and inspection observations, ensuring appropriate root cause analysis, corrective actions, and effectiveness checks.
• Establish and maintain Key Quality Indicators (KQIs) and Key Performance Indicators (KPIs) and continuously improve Quality Systems supporting GCP, GVP, and GLP activities in alignment with FDA, EMA, ICH, and other global regulatory requirements.
• Provide QA oversight and monitoring of computerized systems supporting clinical trials, pharmacovigilance, and nonclinical studies (e.g., EDC, CTMS, eTMF, Safety Systems), ensuring compliance with validation lifecycle requirements, 21 CFR Part 11, EU Annex 11, and applicable CSV & CSA standards.
• Design and maintain quality metrics dashboards, trend analyses, and periodic executive-level reports for Quality Leadership and Quality Management Review (QMR) to enable risk-based decision-making and process improvement.
• Facilitate and monitor internal procedural & training controls across GCP, GLP, and GVP activities to ensure alignment with regulatory requirements and quality system standards.
• Serve as QA Subject Matter Expert (SME) for Quality Systems and Computerized System Validation, providing strategic guidance, technical expertise, and cross-functional leadership to ensure regulatory compliance, inspection readiness, and operational excellence.
Requirements
• Bachelor’s degree in Life Sciences or related field (advanced degree preferred).
• Minimum 10+ years of experience in GxP Quality Assurance within the pharmaceutical, biotechnology, or related regulated industry.
• Minimum 5+ years supporting GCP, GVP, and/or GLP quality systems and compliance areas
• Strong experience developing, monitoring, and reporting quality metrics.
• Experience with QA oversight of computerized system validation (CSV) for clinical and safety systems.
• Experience supporting regulatory inspections and audits (FDA, EMA, MHRA, or other global regulatory bodies).
Nice-to-haves
• Strong analytical skills with ability to interpret quality metrics and identify trends and risks.
• Excellent communication and presentation skills, with ability to present to senior leadership.
• Strong leadership, problem-solving, and organizational skills.
• Ability to work effectively in a fast-paced, cross-functional, and regulated environment.
Apply Now
Apply Now