Senior Manager – Manufacturing Programs - Process Owner Organization

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 role is responsible for overseeing 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, and retain a team of Level 5 Investigators while building investigator capabilities, strengthening technical expertise, 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 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. 

Win 

What We Expect of You 

Basic Qualifications

Doctorate degree and 2 years of  biotechnology or pharmaceutical industry experience
OR
Master’s degree and 6 years of biotechnology or pharmaceutical industry experience
OR
Bachelor’s degree and 8 years of  biotechnology or pharmaceutical industry experience
OR
Associate’s 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.