Remote: External Supply QA Lead for CMOs

Amgen; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Amgen is seeking a Quality professional to lead oversight of drug product and finish drug product CMOs, ensuring GMP compliance across manufacturing, testing and release.

You will represent Amgen in deviations, change controls, CAPAs and batch dispositions, review master batch records, and prepare for regulatory inspections. This role requires cGMP experience and strong cross-functional collaboration in a global biotech environment.

Qualifications

• Experience leading QA reviews of batch records, deviations and CAPAs.
• Proven ability to coordinate with CMOs and regulatory bodies.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead representation, communication and management of quality issues with internal and external partners.
• Serve as main Quality contact for deviations, change controls, CAPAs, and batch disposition.
• Provide quality oversight of manufacturing, testing, and release at CMOs.
• Review Master Batch Records and related cGMP documentation.
• Prepare for regulatory inspections and support inspections at contract sites.
• Identify risk, drive quality improvements and escalate as needed.

Skills

Quality oversight

Regulatory inspections

CAPA management

Deviation & change control

Batch record review

Cross-functional collaboration

Negotiation

Leadership of cross-functional teams

Project management

Education

Master’s degree in Science

Bachelor’s degree in Science

Associate’s degree

High school diploma / GED

cGMP Experience

Job description

Amgen is seeking a Quality professional to lead oversight of drug product and finish drug product CMOs, ensuring GMP compliance across manufacturing, testing and release.

You will represent Amgen in deviations, change controls, CAPAs and batch dispositions, review master batch records, and prepare for regulatory inspections. This role requires cGMP experience and strong cross-functional collaboration in a global biotech environment.