Senior Supplier Quality Manager - Remote

Amgen; Thousand Oaks (CA); Hybrid; USD 132,000 - 179,000; Full time

Job summary

Amgen is seeking a Quality Assurance Senior Manager to oversee the quality oversight of primary component suppliers and be a core member of cross-functional supplier teams. You will ensure supplier performance, lead quality agreements, and prepare sites for inspections, contributing to global regulatory standards.

The role emphasizes leading audits, risk mitigation, and collaboration with operations to drive site performance while maintaining Amgen’s high quality expectations.

Qualifications

• PhD/Master/Bachelor/Associate or HS with qualifying quality experience as stated.
• Experience in biotech/pharmaceutical quality functions preferred.
• Experience overseeing supplier quality and audits is essential.

Responsibilities

• Quality lead for supplier relationships from onboarding to disengagement.
• Manage supplier quality: GDP, GMP, ISO compliance and Amgen standards.
• Prepare sites for inspections and develop inspection playbooks.
• Represent Amgen at regulatory inspections and supplier audits.
• Review and approve supplier investigations, deviations, and CAPAs.
• Drive supplier audit preparation and monitor ongoing supplier performance.
• Coordinate with operations on site performance and issue resolution.

Skills

Quality experience

Audits

Negotiation

Project management

Stakeholder management

Data analytics

AI tools

Supplier relationships

Education

PhD in a related field

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Trackwise

Veeva

Job description

Amgen is seeking a Quality Assurance Senior Manager to oversee the quality oversight of primary component suppliers and be a core member of cross-functional supplier teams. You will ensure supplier performance, lead quality agreements, and prepare sites for inspections, contributing to global regulatory standards.

The role emphasizes leading audits, risk mitigation, and collaboration with operations to drive site performance while maintaining Amgen’s high quality expectations.