Senior Manager, Quality Systems & CAPA Excellence

Revolution Medicines, Inc.; Redwood City (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Revolution Medicines, a late-stage clinical oncology company, seeks a Senior Manager of Quality Management Systems to lead Quality Event processes, training, and continuous improvement. You will partner across Quality, Manufacturing, Supply Chain, Regulatory, and Safety to strengthen QMS execution and ensure inspection readiness.

The role emphasizes mentoring teams, driving CAPA effectiveness, and guiding deviations, investigations, and data integrity initiatives in a fast-paced biopharma

Qualifications

• Bachelor’s degree in a scientific, technical, engineering, pharmacy, or related discipline; equivalent relevant experience may be considered.
• Minimum of 10 years of pharmaceutical or biotechnology Quality Assurance or Quality Systems experience.
• Strong experience with Quality Events, including deviations, investigations, CAPAs, effectiveness checks, product complaints, and temperature excursions.
• Demonstrated ability to train and coach team members on Quality Event processes, systems, investigation practices, and documentation expectations.
• Experience supporting QMS procedures, process improvements, and associated training materials.
• Strong knowledge of GMP requirements, Quality Risk Management, data integrity, and inspection-readiness expectations.
• Experience with eQMS workflows, audits and inspections, Quality metrics, and continuous improvement.
• Strong communication, collaboration, and influencing skills with the ability to work independently and effectively across functions.

Responsibilities

• Lead training, coaching, and ongoing guidance for team members on Quality Events, QMS processes, systems, and associated regulatory expectations.
• Support continuous improvement of QMS procedures, processes, tools, and training materials to enhance clarity, consistency, compliance, and operational effectiveness.
• Provide subject matter expertise and backup review and approval for Quality Events, including deviations and other assigned records.
• Support product complaint and temperature excursion investigations, ensuring appropriate investigation, documentation, escalation, and timely resolution.
• Provide oversight and guidance for CAPA development, implementation, and effectiveness assessments to ensure actions appropriately address identified risks and root causes.
• Drive ongoing audit and inspection readiness for Quality Events by promoting complete, accurate, timely, and inspection-ready documentation.
• Support Quality Event governance, metrics, trending, and identification of systemic issues and opportunities for improvement.
• Partner cross-functionally with Quality, Manufacturing, Supply Chain, Regulatory, Safety, and other stakeholders to resolve quality issues and strengthen QMS execution.
• Promote a strong quality culture through practical guidance, proactive problem solving, and continuous improvement.

Skills

Quality Events

CAPA

eQMS workflows

GMP compliance

Training & coaching

Quality metrics

Data integrity

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Advanced degree or QA certification

Tools

Veeva Quality Vault

Job description

Revolution Medicines, a late-stage clinical oncology company, seeks a Senior Manager of Quality Management Systems to lead Quality Event processes, training, and continuous improvement. You will partner across Quality, Manufacturing, Supply Chain, Regulatory, and Safety to strengthen QMS execution and ensure inspection readiness.

The role emphasizes mentoring teams, driving CAPA effectiveness, and guiding deviations, investigations, and data integrity initiatives in a fast-paced biopharma