Senior Manager Manufacturing Programs Investigations

Senior Manager Manufacturing Programs Investigations

We are seeking a Sr. Manager Manufacturing Programs Investigations to lead the Major Deviation Investigation Team at Amgen North Carolina (ANC).

What You Will Do

• Oversee Major Deviation investigations across ANC operations, including Manufacturing, Quality Control, Facilities & Engineering, Automation, Validation, and other GMP support organizations.
• Lead the Major Deviation Investigation Team responsible for overseeing Major Deviation investigations across ANC operations.
• Establish investigation standards, governance processes, and performance metrics to ensure consistent execution across the site.
• Ensure Major Deviation investigations are completed with high quality, scientific rigor, and within established timelines.
• Oversee investigation strategy development, root cause analysis quality, and CAPA definition for significant quality and compliance events.
• Serve as the primary escalation point for critical investigations and communicate investigation outcomes to site and global leadership.
• Human & Organizational Performance (HOP) Champion
• Foster learning-focused investigation practices that seek to understand process, system, and organizational contributors to events.
• Influence site-wide decision-making related to deviation management strategies, root cause analysis methodologies, CAPA effectiveness, and organizational learning initiatives.

Basic Qualifications

• Doctorate degree and 2 years of biotechnology or pharmaceutical industry experience OR
• Masters degree and 6 years of biotechnology or pharmaceutical industry experience OR
• Bachelors degree and 8 years of biotechnology or pharmaceutical industry experience OR
• Associates degree and 10 years of biotechnology or pharmaceutical industry experience OR
• High school diploma / GED and 12 years of biotechnology or pharmaceutical industry experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications

• 8+ years of biotechnology or pharmaceutical industry experience with progressively increasing responsibility.
• Prior people leadership experience managing and developing investigators or equivalent technical staff.
• Strong background in deviation management, root cause analysis, investigation leadership, and CAPA management.
• Demonstrated experience leading cross-functional investigations involving multiple site functions.
• Experience applying Human and Organizational Performance (HOP), learning-focused investigation techniques, or continuous improvement methodologies.