Quality Compliance External Affairs, Senior Specialist Quality

Role Summary

Quality Compliance External Affairs, Senior Specialist Quality. This role leads pharmacopoeial program management, regulatory intelligence, cross-functional collaboration, and continuous improvement initiatives to advance Amgen's pharmacopoeial compliance and external affairs efforts. Travel domestically and internationally is required up to 10%.

Responsibilities

• Lead project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP), ensuring structured review and implementation of periodic updates.
• 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.
• Networking with peers from other companies (e.g., at conferences or while representing Amgen’s interests in industry associations) and regulators as appropriate.
• Lead and contribute to continuous improvement initiatives to enhance efficiency and effectiveness of the pharmacopeial program.
• Collaborate with SMEs and system owners to optimize databases, tracking tools, and internal processes.
• Support additional projects aligned with departmental priorities and professional development opportunities.
• Travel domestically and internationally as required (approximately up to 10%).

Qualifications

• Required: Doctorate degree and 2 years of quality compliance experience OR Master’s degree and 4 years of quality compliance experience OR Bachelor’s degree and 6 years of quality compliance experience OR Associate’s degree and 10 years of quality compliance experience OR High school diploma / GED and 12 years of quality compliance experience
• Preferred: Background in Quality, QC, QA, Engineering desirable.
• Preferred: Understand quality documentation and laboratory practices including general methodologies, specifications and product quality standards.
• Preferred: Excellent communication skills for both internal conversations and when representing Amgen at external forums
• Preferred: Conflict resolution
• Preferred: Teamwork and Networking
• Preferred: Good organization, planning and prioritization capability
• Preferred: Time management
• Preferred: Attention to details