Remote QA Lead — External Supply

Amgen; United States; Remote; USD 85,000 - 115,000; Full time

Job summary

Amgen is seeking a Quality professional to provide Oversight of Drug Product and Finish Drug Product CMOs. The role focuses on ensuring GMP and regulatory compliance, leading quality issue management, and coordinating with cross-functional teams across internal and external partners.

The position demands strong experience in cGMP, batch release, and QA oversight, including interaction with regulatory bodies during inspections.

Qualifications

• Doctorate or Master’s with related experience required.
• Bachelor’s with related experience acceptable.
• Associate’s with 10 years related experience acceptable.
• High school diploma with 12 years related experience acceptable.

Responsibilities

• Quality oversight of CMOs across manufacturing, testing and release.
• Lead quality issue management with internal and external partners.
• Approve deviations, change controls, CAPAs, and batch disposition.
• Prepare for regulatory inspections and support NPI, tech transfer and filings.

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen is seeking a Quality professional to provide Oversight of Drug Product and Finish Drug Product CMOs. The role focuses on ensuring GMP and regulatory compliance, leading quality issue management, and coordinating with cross-functional teams across internal and external partners.

The position demands strong experience in cGMP, batch release, and QA oversight, including interaction with regulatory bodies during inspections.