Senior Manager Manufacturing Programs Investigations

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Manager Manufacturing Programs Investigations

Live

What You Will Do

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

This leadership roleis responsible foroverseeing Major Deviation investigations across ANC operations, including Manufacturing, Quality Control, Facilities & Engineering, Automation, Validation, and other GMP support organizations.

People Leadership & Team Development

• Lead, coach, develop, andretaina team of Level 5 Investigators while building investigator capabilities, strengthening technicalexpertise, and promoting a culture of collaboration, accountability, and continuous improvement.
• Create an environment of trust and psychological safety where team members feel empowered to raise concerns, challenge assumptions, share diverse perspectives, and contribute openly to problem-solving discussions.
• Develop investigator capabilities through coaching, mentoring, training, and structured development opportunities.
• Encourage a learning-focused culture that emphasizes understanding system vulnerabilities, organizational factors, and sustainable problem resolution.
• Establish clear expectations and performance standards while supporting employee engagement, growth, and career development.
  
  
  

Investigation Leadership & Governance

• 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 Human and Organizational Performance (HOP) principles across the Major Deviation Investigation program.
• Foster learning-focused investigation practices thatseekto 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.
  
  
  

Win

Basic Qualifications

What We Expect of You

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.
• Priorpeopleleadership 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.