Remote External QA Lead — CMO & Compliance

Amgen; Dún Laoghaire; À distance; EUR 90 000 - 150 000; Plein temps

Résumé du poste

Amgen in Ireland seeks a Quality professional to provide oversight of drug product manufacturing at CMOs, ensuring GMP compliance, release and QA review of documentation, and adherence to quality agreements.

You will manage deviations, CAPAs, change controls, lead regulatory inspections readiness, and collaborate across functions to support global product launches and continuous quality improvement.

Qualifications

• PhD or Master with related experience or Bachelor's with 4+ years related experience or Associate with 10+ years related experience or High school with 12+ years related experience.
• Experience in biotech or pharmaceutical quality and manufacturing is preferred.
• cGMP experience and ability to oversee multiple projects across teams.

Responsabilités

• Be an integral quality member of Amgen cross-functional contract manufacturing team.
• Lead representation and management of quality issues with internal and external partners.
• Serve as the main Quality contact for deviations, change controls, CAPAs, and batch disposition.
• Manage CMOs to contract obligations related to Quality Agreement and regulatory requirements.
• Review Master Batch Records and approve cGMP documentation from CMOs/Labs.
• Provide quality oversight of manufacturing, testing, and release of Amgen products at CMOs.
• QA review of documentation associated with batch release for GMP compliance.
• Draft, negotiate and approve quality agreements.
• Prepare for regulatory inspections and represent Amgen at inspections or audits.

Connaissances

Quality oversight

GMP compliance

Contract Manufacturing

Regulatory inspections

CAPA management

Deviations management

QA documentation

Formation

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Description du poste

Amgen in Ireland seeks a Quality professional to provide oversight of drug product manufacturing at CMOs, ensuring GMP compliance, release and QA review of documentation, and adherence to quality agreements.

You will manage deviations, CAPAs, change controls, lead regulatory inspections readiness, and collaborate across functions to support global product launches and continuous quality improvement.