Senior QA Manager, Supplier Quality & Audits (Remote)

Amgen; United States; Remote; USD 132,000 - 179,000; Full time

Job summary

Amgen is seeking a Quality Assurance Senior Manager to lead quality oversight of primary component suppliers, ensuring compliance with GDP, GMP, ISO and Amgen standards. You will partner with cross-functional teams across operations, process development, and supply chain to enable robust supplier performance and continuous improvement.

The role requires extensive experience in biopharma quality, audits, and regulatory interactions, with travel up to 20%.

Qualifications

• Doctorate or Master’s with quality experience required.
• Minimum years of quality leadership experience in biotech/pharma.
• Experience overseeing supplier quality and regulatory inspections.

Responsibilities

• Lead quality oversight of primary component suppliers and drive continuous improvement.
• Prepare suppliers for inspections and represent Amgen at regulatory inspections.
• Review supplier investigations, deviations, CAPA, and change controls.
• Drive supplier audit programs and close out commitments on time.

Skills

Leadership

Project management

Communication

Analytical skills

Stakeholder management

Problem-solving

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Tools

TrackWise

Veeva

Job description

Amgen is seeking a Quality Assurance Senior Manager to lead quality oversight of primary component suppliers, ensuring compliance with GDP, GMP, ISO and Amgen standards. You will partner with cross-functional teams across operations, process development, and supply chain to enable robust supplier performance and continuous improvement.

The role requires extensive experience in biopharma quality, audits, and regulatory interactions, with travel up to 20%.