Global Quality & Compliance Director

Revolution Medicines; San Francisco (CA); Sur place; USD 186 000 - 233 000; Plein temps

Résumé du poste

Revolution Medicines is seeking a Senior leader to oversee Global Quality Systems Monitoring & Excellence, ensuring governance, compliance, and continuous improvement across the QMS at our Redwood City, CA headquarters.

You will drive audit readiness, KPIs, and cross-functional investigations, leading a team to resolve compliance risks and deliver strategic quality initiatives leveraging AI and data analytics.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related field.
• 10+ years of progressive Quality Assurance/Quality Systems experience in biotech/pharma/medical device, including people leadership.
• Strong knowledge of global GxP regulations, including FDA, EMA, ICH, and applicable international quality standards.
• Demonstrated experience leading regulatory inspections, internal audits, Quality Management Reviews (QMRs), and Quality Systems governance.
• Experience with electronic Quality Management Systems (eQMS), such as Veeva Vault or equivalent.
• Excellent leadership, communication, strategic thinking, project management, and stakeholder management skills.

Responsabilités

• Lead Global Quality Systems Monitoring & Excellence program to ensure governance, compliance, and continuous improvement across the Quality Management System (QMS).
• Drive global audit and regulatory inspection readiness by leading inspection planning, mock inspections, execution support, response coordination, and post-inspection remediation.
• Develop and monitor Quality KPIs/KQIs, analyze trends, identify systemic risks, and provide executive reporting through Quality Management Reviews (QMRs).
• Perform Quality System health assessments and effectiveness reviews to identify compliance gaps and drive sustainable improvements.
• Oversee CAPA governance related to internal audits & inspections, root cause analysis, effectiveness verification, and closure of audit and inspection commitments.
• Lead the management of critical quality issues and escalations, facilitate timely cross-functional investigations and remediation plans, and ensure effective resolution of compliance risks and regulatory commitments.
• Partner with cross-functional stakeholders to standardize, simplify, and optimize Quality processes while ensuring compliance with global GxP regulations.
• Lead regulatory intelligence activities and translate evolving global regulatory expectations into Quality System enhancements.
• Leverage AI, automation, data analytics, and digital Quality platforms to enhance compliance monitoring, executive reporting, and operational excellence.
• Build and lead a high-performing team while fostering a culture of quality, compliance, inspection readiness, and continuous improvement across the organization.

Connaissances

QA leadership

GxP regulations

Regulatory inspections

eQMS (Veeva Vault)

Data analytics

Executive reporting

Stakeholder management

Project management

Communication

Strategic thinking

Formation

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related field

Master's degree preferred

Outils

Veeva Vault

eQMS

Description du poste

Revolution Medicines is seeking a Senior leader to oversee Global Quality Systems Monitoring & Excellence, ensuring governance, compliance, and continuous improvement across the QMS at our Redwood City, CA headquarters.

You will drive audit readiness, KPIs, and cross-functional investigations, leading a team to resolve compliance risks and deliver strategic quality initiatives leveraging AI and data analytics.