Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence

Role: Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence, responsible for leading Amgen's enterprise-wide audit organization and compliance analytics to proactively identify and mitigate regulatory and quality risks. Responsibilities include establishing strategic direction, overseeing global GMP/GDP audits of manufacturing sites, suppliers, and distribution, and developing a predictive compliance intelligence platform leveraging advanced analytics and AI. The role requires integrating audit data with inspection outcomes, regulatory trends, and quality signals to enable early intervention, systemic risk identification, and continuous improvement. Collaboration spans regulatory reporting, inspection readiness, and external affairs, providing insights to improve inspection outcomes and compliance standards. Qualifications: Doctorate with 5+ years or Master’s with 9+ years, or Bachelor’s with 11+ years of biologics manufacturing and regulatory compliance experience, including 5+ years of leadership managing teams, projects, or programs. Preferred skills encompass extensive leadership in pharma/biotech quality, auditing, regulatory affairs, and experience building or transforming enterprise compliance capabilities, especially in applying analytics, AI, or digital tools. High-value specifics involve biologics manufacturing, GxP compliance, oversight of GMP/GDP audits, and a focus on emerging risks, inspection trends, and systemic quality issues. The role reports to senior leadership, involves cross-functional partnership, and may include global travel. The work setup may be hybrid or remote, with a focus on strategic and technical leadership within a global biotech setting.