Deputy Archivist

Role Summary

Deputy Archivist at Amgen serves as the subject matter expert (SME) for GLP archiving, ensuring the integrity, traceability, and availability of archived GLP data in accordance with applicable regulations and internal Amgen requirements. The role plays a critical part in inspection readiness across global regulatory authorities. It leads complex archiving strategies and collaborates with cross-functional teams to ensure lifecycle management of GLP records.

Responsibilities

• Serve as the GLP Archive SME, ensuring alignment with global regulations and Amgen quality standards/policies.
• Lead and oversee GLP archive operations, including intake, indexing, secure storage, retrieval, retention, and authorized destruction of records and specimens.
• Serve as backup GLP Archivist for all archive-related duties, including Research Satellite Archive and eArchive.
• Partner with Archive vendors to maintain precise archive inventories and material management.
• Develop and implement compliant archiving strategies to support evolving regulatory expectations and digital transformation initiatives
• Partner with Test Site Management, Principal Investigators, CRO Archivists, Quality, and other nonclinical teams to ensure lifecycle management of GLP records.
• Create, own, update, and maintain archive-related SOPs, work instructions, and training materials.
• Assess regulatory impact of changes to archiving processes and systems; provide risk-based recommendations to leadership.
• Ensure data integrity, confidentiality, and adherence to Amgen’s information governance and data protection standards.

Qualifications

• Doctorate degree OR Master’s degree and 2 years of Experience working in healthcare regulated environments (eg FDA, OECD, LGL)
• OR Bachelor’s degree and 4 years of Experience working in healthcare regulated environments (eg FDA, OECD, LGL)
• OR Associate’s degree and 8 years of Experience working in healthcare regulated environments (eg FDA, OECD, LGL)
• OR High school diploma / GED and 10 years of Experience working in healthcare regulated environments (eg FDA, OECD, LGL)