Senior Supplier Quality Lead – Remote & Global Compliance

Amgen; De Pere (WI); On-site; USD 132,000 - 179,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision insurance

Life and disability insurance

Flexible spending accounts

Annual bonus program

Long-term incentives (stock)

Job summary

Amgen seeks a Quality Assurance Senior Manager to oversee primary component supplier quality. You will lead supplier relationships, drive proactive quality management, and ensure regulatory compliance across GDP, GMP, ISO standards.

The role includes preparing sites for inspections, negotiating quality agreements, and coordinating with cross-functional teams to sustain supplier performance. Key qualifications include advanced biotech/pharma quality experience and proven audit leadership.

Qualifications

• Doctorate degree with 2+ years in Quality or
• Master's with 4+ years in Quality or
• Bachelor's with 6+ years in Quality or
• Associate's with 10+ years in Quality or
• High school diploma with 12+ years in Quality

Responsibilities

• Act as the quality lead for supplier relationships from onboarding to disengagement.
• Monitor supplier quality to ensure GDP, GMP, ISO compliance.
• Negotiate and own quality agreements with suppliers.
• Prepare sites for inspections with playbooks and readiness.
• Represent Amgen at supplier inspections and audits as needed.
• Review supplier investigations, events and change notifications.
• Approve deviations, change controls, CAPA, CAPA EVs.
• Identify and mitigate supplier-related risks and escapes.
• Perform Person in Plant activities when required.
• Drive supplier audit commitments and lead audit prep.
• Monitor supplier status and drive improvements.
• Collaborate with Operations site lead on site performance.
• Implement GMP requirements internally and externally.

Education

Doctorate degree and 2 years of Quality experience OR

Master's degree and 4 years of Quality experience OR

Bachelor's degree and 6 years of Quality experience OR

Associate's degree and 10 years of Quality experience OR

High school diploma / GED and 12 years of Quality experience

Tools

Trackwise

Veeva

Job description

Amgen seeks a Quality Assurance Senior Manager to oversee primary component supplier quality. You will lead supplier relationships, drive proactive quality management, and ensure regulatory compliance across GDP, GMP, ISO standards.

The role includes preparing sites for inspections, negotiating quality agreements, and coordinating with cross-functional teams to sustain supplier performance. Key qualifications include advanced biotech/pharma quality experience and proven audit leadership.