Senior Manager, Quality Validation – PPQ & CPV Expert

revolutionmedicines; Redwood City (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Revolution Medicines in Redwood City, CA seeks a Senior Manager, Quality Validation to lead QA oversight for validation across external commercial manufacturing networks. You will focus on PPQ and CPV, while supporting DS/DP validation and related lifecycle activities to ensure robust quality and compliance.

The role requires a Bachelor's degree in a scientific discipline and 8+ years in GMP quality and commercial manufacturing, with strong regulatory knowledge and cross-functional collaboration

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline.
• 8+ years of experience in GMP Quality and commercial manufacturing operations.
• Experience in PPQ and CPV validation lifecycle.
• Experience overseeing validation activities with CMOs/external partners.
• Strong knowledge of GMP regulations and regulatory guidance.
• Experience with regulatory inspections.
• Excellent communication and risk-based decision making.

Responsibilities

• Provide QA oversight of validation activities across CMOs and external partners.
• Represent QA on validation lifecycle activities including PPQ and CPV.
• Review validation plans, protocols, reports, risk assessments and investigations.
• Collaborate with stakeholders to address validation strategy and compliance risks.
• Support GMP quality activities and change controls.
• Monitor validation metrics and communicate status to leadership.
• Support inspection readiness and regulatory inspections.
• Promote collaboration across internal and external teams.

Skills

QA oversight

PPQ

CPV

Validation lifecycle

Regulatory knowledge

Risk assessment

Cross-functional

Communication

Education

Bachelor's degree in science/engineering

Job description

Revolution Medicines in Redwood City, CA seeks a Senior Manager, Quality Validation to lead QA oversight for validation across external commercial manufacturing networks. You will focus on PPQ and CPV, while supporting DS/DP validation and related lifecycle activities to ensure robust quality and compliance.

The role requires a Bachelor's degree in a scientific discipline and 8+ years in GMP quality and commercial manufacturing, with strong regulatory knowledge and cross-functional collaboration