Senior Machine Learning Scientist I

Role: Senior Manager, Quality Validation overseeing validation activities within GMP commercial manufacturing for Revolution Medicines' oncology products, primarily focused on Process Performance Qualification (PPQ) and Continued Process Verification (CPV). Responsibilities include providing QA oversight across external CMOs and partners, reviewing validation plans, reports, risk assessments, and process data; ensuring compliance with global regulatory standards; supporting broader GMP quality activities such as deviations, investigations, and change controls; and contributing to inspection readiness. Requirements: Bachelor's in scientific, engineering, or technical field; 8+ years in pharmaceutical GMP quality and manufacturing, with demonstrated expertise in validation lifecycle management, especially PPQ and CPV. Knowledge of process validation, global GMP regulations, and experience with commercial product lifecycle management is essential. Preferred skills include experience with oral solid dosage forms, lifecycle management across multiple CMOs, statistical trending of CPV data, and support for late-stage development and technology transfer. Stakeholder collaboration with internal teams and external manufacturing partners is critical. Work setup: Not specified, but involves external manufacturing oversight with a focus on commercial-stage products.