Senior Manager Corporate Quality Compliance
Core
Execute Global Quality Compliance tasks and projects to achieve corporate and departmental goals, including leading audits of the Quality Management System, sites, and suppliers.
Role type
Senior Manager, Corporate Quality Compliance
Builds
Compliance with global regulations and internal standards across the biotech organization
Domain
Biotechnology / Pharmaceutical Quality Assurance
Deliverable
client delivery (regulatory compliance and audit execution)
Required skills
Global Quality Compliance auditing, Quality Management System (QMS) assessment, Regulatory requirements knowledge, Action plan assessment, Executive risk reporting, Cross-functional team leadership, QA approval for Quality Events (Deviation, CAPA, Change Control), Aseptic Processing, Drug Product/Substance knowledge, Data Integrity
Preferred skills
Internal audit experience, Contract laboratory/CMO auditing, International regulations knowledge, International travel
Technologies
None explicitly listed
Responsibilities
Coordinate and lead Global Quality Compliance Audits of Corporate QMS, Amgen sites, Contract facilities, and Suppliers; Ensure completion and maintenance of assigned training for audit support; Support preparation of annual audit plans; Assess state of compliance with regulations and participation in action plans to correct deficiencies; Provide technical and organizational leadership toward resolving site and multi-site compliance issues; Alert executive management of significant quality and compliance risks; Serve as subject matter expert on global regulated requirements; Provide support for domestic and international Regulatory Authority Inspections; Serve as senior Global Quality Compliance representative on cross-functional teams; Interact with functional area leads to align Amgen Standards with regulations; Provide support for audit and inspection metrics; Support Continual Improvement initiatives; Own or perform QA approval for DQMS Quality Event records.
Seniority
Senior Manager, hands-on leadership
