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Role Description: This role is an individual contributor role that provides critical support to Product Quality Teams (PQTs) for late-stage clinical and commercial products. In this role, you will serve as a primary author of technical and regulatory reports, manage GMP data within compliant systems, and help ensure accuracy, completeness, and compliance across global submissions. You will also play an integral role in maintaining Amgen’s electronic databases and mapping tools, supporting continuous improvement initiatives, and providing peer training as needed. This role requires strong expertise in GMP compliance, technical writing, and cross-functional collaboration to drive high-quality outcomes under tight timelines.
Job Responsibility
Navigate and execute transactions in GMP systems (Empower, LIMS, Veeva, Spotfire)
Work closely with in the product Quality organization to drive standardization of data, and chromatographic overlay activities
Author and maintain GMP technical reports supporting regulatory filings within quality systems (e.g., Veeva)
Collate, review, verify, and archive GMP data for late-stage clinical and commercial products
Ensure accuracy and completeness of product data with high attention to detail
Collaborate across global teams and time zones, effectively communicating findings and project updates
Requirements
Strong understanding of GMP requirements, US FDA, and ICH regulations
Proven technical expertise in Chromatographic techniques /software and overlays
Expertise in GMP systems (Veeva, Empower, LIMS, Spotfire)
Strong data management, analytical, and problem-solving skills
Experience supporting cross-functional teams in matrixed, global environments
Proficiency in MS Office (Word, Excel, PowerPoint, Teams)
Excellent written and verbal communication across all levels of the organization
Continuous improvement mindset with experience applying lean practices
Nice to have
Knowledge of stability data management and annual product review
Experience in assembling annual product reviews
Experience in business process improvement and electronic data tool development