Senior Associate Quality Assurance - Global Supply Quality

About the role

Senior Associate Quality Assurance - Global Supply Quality at Amgen. Responsible for quality oversight of alliance partnerships and external supply portfolio. Works with cross-functional teams including Contract & Development Manufacturing, Process Development, Supply Chain, Business Development. Performs QA contact role, partner assessments, support partnership alliance quality tasks, portfolio strategy, audits, inspections, SOPs, GMP/GDP compliance, risk management, operational improvement, metrics ownership. Requires Master’s or Bachelor’s with 1-5 years experience or Diploma with 7-9 years. Must understand GMP/GDP, raw material compendial testing, supplier quality oversight, technical writing, alliance management. Preferred: continuous improvement, lean, supply chain processes, project management, analytical skills, self-starter, GMP/GDP knowledge, communication, Microsoft Office, multitasking.

What you’ll do

• Perform QA contact role for partners
• Assess partners for change control and deviations
• Support partnership alliance quality tasks
• Assist portfolio strategy execution and due diligence
• Collaborate with key stakeholders for end-to-end process
• Prepare, review, approve SOPs and GMP/GDP docs
• Collaborate with external suppliers and partners
• Incorporate risk management into supply lifecycle
• Support audits, inspections, and operational improvement
• Develop practical solutions aligned with objectives
• Own business metrics and performance assessments
• Work independently with minimal supervision

What you’ll bring

• Master’s or Bachelor’s with 1-5 yrs experience OR Diploma with 7-9 yrs experience
• Understand GMP/GDP requirements
• Familiar with raw material compendial testing
• Oversee supplier quality of external parties
• Strong technical writing skills
• Strong alliance management experience

Nice to have

• Continuous improvement mindset with lean experience
• Understand end-to-end supply chain processes
• Project management across multiple departments and geographies
• Quick process understanding, insight, visualization
• Strong analytical and problem-solving skills
• Independent self-starter, works autonomously under pressure
• GMP/GDP knowledge and pharma regulations
• Energetic, detail oriented, highly motivated
• Change management skills
• Effective communication across all levels
• Microsoft Office proficiency (Excel, Word, PowerPoint)
• Multi-task and prioritize

Skills

Education

Master's