Global Supplier Quality Senior Manager

Regulatory Jobs; United States; Hybrid; USD 132,000 - 179,000; Full time

Benefits offered by this job

Total rewards package

Stock-based incentives

Flexible work options

Job summary

Amgen is seeking a Quality Assurance Senior Manager to lead the quality oversight of primary component suppliers. You will collaborate with cross-functional teams to ensure compliance with GDP, GMP, ISO standards and Amgen's expectations.

You will drive supplier audits, manage quality agreements, and prepare sites for inspections. Remote flexibility is available and travel up to 20% is expected.

Qualifications

• Doctorate or advanced degree with significant quality experience.
• Experience overseeing supplier quality and audits is preferred.
• Strong knowledge of GMP, GDP, ISO, and regulatory expectations.

Responsibilities

• Lead quality oversight of primary component suppliers across onboarding to disengagement.
• Ensure regulatory compliance and proactive quality management with suppliers.
• Negotiate and own quality agreements with external partners.
• Prepare supplier sites for inspections and develop inspection playbooks.
• Represent Amgen during external inspections and audits as needed.
• Review and approve supplier investigations, deviations, and CAPAs.

Skills

Quality oversight

Supplier management

Audits

GMP/GDP/ISO

Cross-functional leadership

Regulatory inspections

Negotiation

Project management

Data analytics/AI tools

Education

Doctorate degree

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 lead the quality oversight of primary component suppliers. You will collaborate with cross-functional teams to ensure compliance with GDP, GMP, ISO standards and Amgen's expectations.

You will drive supplier audits, manage quality agreements, and prepare sites for inspections. Remote flexibility is available and travel up to 20% is expected.