Senior Manager, Quality Validation

Role: Senior Manager, Quality Validation at a late-stage oncology biopharma developing RAS-targeted therapies, focusing on validation oversight for commercial manufacturing. Responsibilities: oversee validation activities including PPQ and CPV across external CMOs supporting drug substance, drug product, and packaging; review validation plans, reports, and risk assessments; ensure compliance with global GMP standards; support GMP operations, deviations, investigations, and change controls; monitor validation metrics and assist regulatory inspection readiness. Requirements: Bachelor's in science, engineering, or technical field; 8+ years in GMP pharmaceutical quality and manufacturing; proven experience in validation lifecycle, especially PPQ and CPV; knowledge of process validation principles, global GMP regulations, and experience supporting commercial product lifecycle. Preferred: experience with oral solid dosage forms, lifecycle management across multiple CMOs, statistical trending, and post-approval activities. High-value specifics: focus on commercial validation, validation of manufacturing, packaging, and transportation, with a regulatory compliance emphasis. Collaboration with internal teams and external manufacturing partners, reporting to Quality leadership. Work setup: onsite at Redwood City, CA, with a salary range of $164,000 to $205,000; benefits and total rewards include equity and development opportunities.