Remote External QA Manager for CMO Partnerships

Amgen; Ireland; À distance; EUR 90 000 - 150 000; Plein temps

Avantages offerts par ce poste

Base salary

Total Rewards Plans aligned with local

Résumé du poste

Amgen is seeking a Quality professional to oversee Drug Product CMOs and ensure GMP compliance across manufacturing, testing, and release processes. You will act as the primary quality contact for deviations, CAPAs, and batch disposition, managing CMOs to contractual quality agreements and regulatory requirements.

You will lead inspections readiness, coordinate with internal teams, and drive risk management across Amgen sites and contract partners, enabling successful regulatory outcomes and

Qualifications

• Doctorate or equivalent with related experience.
• Associate degree +10 years or high school diploma +12 years related experience.
• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry.

Responsabilités

• Be an integral quality member of Amgen cross-functional contract manufacturing team.
• Lead the representation, communication and management of quality issues with internal and external partners.
• Serve as the main Quality point of contact and approver for deviations, change controls, CAPAs, and batch disposition.
• Manage CMOs to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements.
• Review completed production batch records and approve master batch records and other cGMP documents from CMOs/Contract Laboratories.
• Provide quality oversight of the manufacturing, testing, and release of Amgen products at CMOs.
• QA review of all documentation associated with batch release to ensure GMP compliance.
• Lead inspection preparations and represent Amgen at regulatory inspections when required.
• Identify risk at the CMO/testing labs and elevate to management.
• Monitor quality metrics and communicate site performances to Amgen and Contract Manufacturer.

Connaissances

Quality management

Cross-functional leadership

Leadership

Project coordination

Formation

Doctorate degree

Master’s degree & 2 years of related experience

Bachelor’s degree & 4 years of related experience

Associate’s degree & 10 years of related experience

High school diploma / GED & 12 years of related experience

Description du poste

Amgen is seeking a Quality professional to oversee Drug Product CMOs and ensure GMP compliance across manufacturing, testing, and release processes. You will act as the primary quality contact for deviations, CAPAs, and batch disposition, managing CMOs to contractual quality agreements and regulatory requirements.

You will lead inspections readiness, coordinate with internal teams, and drive risk management across Amgen sites and contract partners, enabling successful regulatory outcomes and