Senior Manager, Quality Validation

Socket.dev; Redwood City (CA); On-site; USD 164,000 - 205,000; Full time

Job summary

Revolution Medicines seeks a Senior Manager, Quality Validation to lead QA oversight of validation for external manufacturing networks, focusing on PPQ and CPV across Drug Substance, Drug Product, and packaging processes.

You will review validation documentation, manage lifecycle activities, and support GMP operations, deviations, CAPAs, and regulatory inspections to ensure continued process control and product quality.

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline required.
• 8+ years in pharmaceutical GMP quality and commercial manufacturing operations.
• Experience overseeing validation lifecycles, PPQ and CPV; packaging, cleaning, and transport validation preferred.

Responsibilities

• Provide QA oversight of validation activities across CMOs and external partners for commercial products (PPQ/CPV emphasis).
• Serve as QA Validation representative for programs and sites, overseeing validation lifecycle activities and change controls.
• Review validation plans, protocols, reports, risk assessments, and CPV data; escalate adverse trends.

Skills

QA oversight

PPQ & CPV

Regulatory knowledge

Communication

Stakeholder management

MS Office

Electronic quality systems

GMP compliance

Education

Bachelor's degree in scientific, engineering or technical discipline

Job description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Revolution Medicines is seeking a Senior Manager, Quality Validation who will play a key role within Quality Assurance, providing quality oversight and operational leadership for validation activities across RevMed’s external commercial manufacturing network. The role will have primary responsibility for QA oversight of Process Performance Qualification (PPQ) and Continued Process Verification (CPV), as well as other validation activities supporting commercial manufacturing, packaging, and product lifecycle management. In addition to validation responsibilities, this individual will provide broader QA support across GMP operations and quality systems based on business needs.

Responsibilities:

• Provide QA oversight of validation activities across CMOs and external partners supporting RevMed commercial products, including Drug Substance (DS), Drug Product Intermediates (DPI), Bulk Drug Product (BDP), Finished Product (FP), and Packaged Product, with primary emphasis on Process Performance Qualification (PPQ) and Continued Process Verification (CPV).
• Serve as the QA Validation representative for assigned commercial programs and external manufacturing sites, providing oversight and approval of validation lifecycle activities, including PPQ, CPV, cleaning, packaging, and transportation/shipping validation, and ensuring activities are appropriately planned, executed, documented, and maintained throughout the commercial product lifecycle.
• 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, identify emerging risks, and ensure appropriate investigation and escalation of 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, providing guidance consistent with current global regulatory requirements, industry standards, and best practices.
• 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 supporting commercial manufacturing and product lifecycle management.
• Establish, monitor, and communicate validation and process performance metrics, including PPQ/CPV status, trends, risks, and compliance issues, and elevate 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.

Required Skills, Experience and Education:

• A Bachelor's degree in a scientific, engineering or technical discipline is required.
• A minimum of 8 years of experience in the pharmaceutical industry demonstrated experience in GMP Quality and commercial manufacturing operations.
• Demonstrated experience providing QA oversight of validation lifecycle activities, with strong experience in Process Performance Qualification (PPQ) and Continued Process Verification (CPV); experience with packaging, cleaning, and transportation/shipping validation is 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 elevate significant quality and compliance risks.
• Proficiency with electronic quality systems and Microsoft Office applications.

Preferred Skills:

• Experience supporting validation and lifecycle management of commercial pharmaceutical products across multiple CMOs and external manufacturing partners.
• Experience with late-stage development, commercial launch, technology transfer, and post-approval lifecycle management activities.
• Experience with statistical trending and evaluation of CPV data, process performance, and continued process control.
• Experience working with oral solid dosage forms and associated manufacturing and packaging operations.

#LI-JC1 #LI-Hybrid

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [e-mail].

Base Pay Salary Range

$164,000—$205,000 USD