Senior QA Validation Lead – Commercial Pharma

Regulatory Jobs; Redwood City (CA); Híbrido; USD 150.000 - 190.000; Jornada completa

Descripción de la vacante

Revolution Medicines is seeking a Senior Manager, Quality Validation who will lead QA oversight of validation activities across CMOs and external partners for commercial products. The role focuses on PPQ, CPV, and related validation lifecycle activities within a GMP framework.

The position requires a scientific/engineering degree and at least 8 years in GMP quality and commercial manufacturing, with strong regulatory knowledge and cross-functional collaboration skills to support readiness and

Formación

• Bachelor's degree in a scientific, engineering or technical discipline is required.
• Minimum 8 years of experience in GMP Quality and commercial manufacturing operations.
• Demonstrated experience providing QA oversight of validation lifecycle activities, with strong PPQ and CPV; packaging, cleaning, and transportation/shipping validation experience preferred.
• Experience providing Quality oversight of CMOs and external partners supporting commercial manufacturing, packaging, testing, and validation activities.
• Strong knowledge of process validation lifecycle principles and applicable U.S. and global GMP regulations, regulatory guidance, and industry practices.
• Experience supporting commercial readiness, inspection readiness, and regulatory inspections, including domestic and international health authorities.
• Demonstrated ability to critically evaluate complex technical and compliance issues, assess risk, and make sound, risk-based Quality decisions.
• Strong communication, collaboration, and stakeholder management skills, with the ability to effectively work with cross-functional teams and external partners.
• Ability to work independently, manage multiple priorities and aggressive timelines, and effectively escalation significant quality and compliance risks.
• Proficiency with electronic quality systems and Microsoft Office applications.

Responsabilidades

• Provide QA oversight of validation activities across CMOs and external partners supporting RevMed commercial products, including PPQ and CPV.
• Serve as the QA Validation representative for assigned commercial programs and external manufacturing sites, providing oversight and approval of validation lifecycle activities.
• Provide QA review and approval of validation plans, protocols, reports, risk assessments, process performance evaluations, and associated investigations and change controls; review CPV data and process performance trends to confirm continued process control and escalate adverse trends.
• Represent QA on cross-functional teams and partner with internal and external stakeholders to address validation strategy, planning, technical issues, and compliance risks.
• Provide QA oversight and support for broader GMP Quality activities, including deviations, investigations, CAPAs, change controls, specifications, master and executed batch records, validation documentation, and other quality system activities.
• Establish, monitor, and communicate validation and process performance metrics, including PPQ/CPV status, trends, risks, and compliance issues, and escalate significant concerns to Quality leadership.
• Lead or support the development, periodic review, and revision of GMP procedures and participate in inspection readiness activities, regulatory inspection support, and other commercial readiness initiatives as needed.
• Build trusted, collaborative relationships with internal and external stakeholders that promote open communication, teamwork, and effective execution.

Conocimientos

QA Oversight

PPQ & CPV

GMP Compliance

CMO Coordination

Regulatory Knowledge

Risk Assessment

Cross-functional Collaboration

Quality Systems

Documentation & Records

Project Management

Educación

Bachelor's degree in a scientific, engineering or technical discipline

Herramientas

Electronic Quality Systems

Microsoft Office

Descripción del empleo

Revolution Medicines is seeking a Senior Manager, Quality Validation who will lead QA oversight of validation activities across CMOs and external partners for commercial products. The role focuses on PPQ, CPV, and related validation lifecycle activities within a GMP framework.

The position requires a scientific/engineering degree and at least 8 years in GMP quality and commercial manufacturing, with strong regulatory knowledge and cross-functional collaboration skills to support readiness and