• Lead project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP) • Coordinate cross-functional teams and site points of contact at global manufacturing sites to execute required changes in alignment with compliance timelines. • Ensure all pharmacopeial changes are appropriately assessed, documented, tracked, and maintained in a current state within Amgen systems. • Author compendial assessments within Amgen’s documentation management systems for audit readiness purposes. • Proactively monitor early signals, emerging trends, and evolving regulatory issues impacting global operations as it relates to pharmacopoeia matters. • Represent Amgen’s approved positions in external organizations and trade associations as assigned, to influence and shape pharmacopeial public standards. • Liaise with regulators through industry associations, supporting advocacy and alignment efforts. • Partner with internal SMEs to ensure scientific alignment on pharmacopeial developments and regulatory changes. • Support knowledge-sharing across functions to enhance understanding of external landscape developments. • Provide back-up support within External Affairs as needed to ensure business continuity. • Networking across various Amgen functions including Quality Control, Quality Assurance, Process Development/Attribute Sciences, Material Quality, Engineering, Product Quality, Microbiology, Toxicology, GRAAS-CMC and R&D Policy. • Liaise with Governmental Affairs, Supply Chain, manufacturing / development sites, External Quality (CMO) and affiliates/IDQ, as appropriate • Lead and contribute to continuous improvement initiatives to enhance efficiency and effectiveness of the pharmacopeial program.