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.

• 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.

• 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.

• experience with oral solid dosage forms;
• lifecycle management across multiple CMOs;
• statistical trending;
• 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.