Global Quality Compliance Senior Manager | Remote/Hybrid

Amgen SA; United States, Northern America, Americas; Hybride; USD 150 000 - 190 000; Plein temps

Avantages offerts par ce poste

Total Rewards Plan

Stock-based long-term incentives

Retirement and Savings Plan

Flexible work models

Résumé du poste

Amgen in the U.S. seeks a Senior Manager in Global Quality Compliance to lead audits, coordinate global regulatory activities, and drive sustainability of corrective actions across corporate quality systems, sites, and partners.

The role requires strong leadership, cross‑functional collaboration, and strategic thinking to ensure compliance with evolving regulations; travel is approximately 50% domestically and internationally, with a focus on quality governance and continuous improvement.

Qualifications

• Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity.
• Certified Quality Auditor (CQA) or equivalent.
• Travel: Domestic and International Approximately 50%.

Responsabilités

• Execute Global Quality Compliance audits of Corporate Quality Management System, sites, affiliates, suppliers and partners.
• Maintain training and ensure regulatory requirements are understood and applied.
• Support annual audit plans and assessment of action plans to correct deficiencies.
• Provide leadership toward resolving site and multi-site compliance issues.
• Interact with cross-functional teams to align Amgen standards with regulations and expectations.
• Support regulatory inspections and contribute to audit/inspection metrics and continual improvement initiatives.

Connaissances

Auditor experience

People leadership

Regulatory knowledge

Travel readiness

Formation

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Description du poste

Amgen in the U.S. seeks a Senior Manager in Global Quality Compliance to lead audits, coordinate global regulatory activities, and drive sustainability of corrective actions across corporate quality systems, sites, and partners.

The role requires strong leadership, cross‑functional collaboration, and strategic thinking to ensure compliance with evolving regulations; travel is approximately 50% domestically and internationally, with a focus on quality governance and continuous improvement.