Sr Assoc QA - Global Supply Quality
Core
Oversees quality for Amgen's alliance partnerships and external supply portfolio, ensuring compliance with quality agreements and GMP/GDP standards.
Role type
Senior Associate Quality Assurance (External Supply & Alliance Management)
Builds
External supply portfolio quality oversight and alliance partnership compliance
Domain
Biotechnology / Pharmaceutical Supply Chain
Deliverable
client delivery
Required skills
GMP/GDP compliance, supplier quality oversight, quality agreement management, change control assessment, deviation record review, SOP preparation and approval, risk management strategy, stakeholder collaboration, business metrics ownership
Preferred skills
Lean practices, end-to-end supply chain process knowledge, cross-functional project management, analytical problem-solving, change management
Technologies
Microsoft Office (Excel, Word, PowerPoint)
Responsibilities
Perform QA contact role for partners to ensure adherence to quality agreements; Conduct partner/client assessments for change control and deviation records; Prepare and approve SOPs and GMP/GDP documentation; Support due diligence and audit activities; Incorporate risk management into the external supply lifecycle; Own business metrics and performance assessments for supplier relationships.
Seniority
Mid-Senior, hands-on IC
