Senior Manager Manufacturing Programs – Investigations

Amgen•Holly Springs, NC

12d•Onsite

About The Position

Amgen is 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. The Amgen FleX batch facility is Amgen's newest and most advanced drug substance manufacturing plant, combining the latest in single-use technologies with traditional stainless steel equipment for maximum flexibility. The facility integrates sustainability innovations to reduce carbon and waste, aligning with Amgen's plan to be a carbon-neutral company by 2027.

Requirements

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
Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
Managerial experience may run concurrently with the required technical experience.

Nice To Haves

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.

Responsibilities

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.
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.
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.