Senior Manager, Quality Validation

Revolution Medicines seeks a Senior Manager of Quality Validation to oversee QA activities for commercial manufacturing across external partners. The role focuses on process performance qualification, continued process verification, and broader quality systems support for oncology drug products.

Responsibilities

• Provide QA oversight of validation activities across CMOs for drug substance, intermediates, bulk product, and finished product
• Serve as QA validation representative for commercial programs, approving lifecycle activities including PPQ, CPV, and packaging validation
• Review and approve validation protocols, reports, risk assessments, and associated investigations and change controls
• Represent quality on cross-functional teams addressing validation strategy, technical issues, and compliance risks
• Monitor validation metrics, process performance trends, and escalate significant concerns to quality leadership

Requirements

• Extensive experience in pharmaceutical quality assurance and validation activities
• Deep knowledge of process performance qualification and continued process verification
• Strong understanding of GMP regulations, global regulatory requirements, and industry standards
• Experience managing quality oversight across contract manufacturing organizations
• Proven ability to lead cross-functional teams and external stakeholder engagement
• Expert-level skill in validation documentation, risk assessment, and quality systems