Senior Specialist – Investigations & Regulatory Inspections

Role: Senior Specialist in Investigations & Regulatory Inspections at Amgen's biologics manufacturing site, focusing on managing complex deviation investigations, ensuring inspection readiness, and supporting regulatory compliance. Responsibilities: lead root cause analyses, develop CAPAs, prepare for inspections, author and review investigation documentation, and coordinate cross-functional teams during audits. Requirements: Doctorate with 2+ years, Master's with 4+ years, Bachelor's with 6+ years, or equivalent experience in biotech/pharma manufacturing, microbiology, or quality assurance. Preferred: 7+ years industry experience, expertise in investigation management, GMP regulations (FDA, EMA), and proficiency with Veeva QMS; strong project management and leadership skills. HighValue: biologics drug substance manufacturing, deviations investigation, inspection readiness, regulatory compliance, GMP standards, and cross-functional collaboration. WorkSetup: flexible, with remote work options.