Manager Manufacturing Programs - Investigations

Amgen SA; Holly Springs (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Amgen North Carolina Biologics Drug Substance Manufacturing plant seeks a Manager of Manufacturing Programs – Investigations to lead the Manufacturing Investigations team. You will develop a high-performing group that conducts timely, thorough, and compliant deviation investigations while driving operational excellence, inspection readiness, and continuous improvement.

The role requires fostering trust, guiding root-cause analyses, CAPA, and partnering across Manufacturing, Quality, Engineering,

Qualifications

• Doctorate degree required.
• Master's degree with 3+ years related experience.
• Bachelor's degree with 5+ years related experience.
• Associate's degree with 10 years related experience.
• High school diploma with 12 years related experience.
• Experience directly managing people or leading teams is required.

Responsibilities

• Lead, develop, coach, and mentor a team of Manufacturing Investigation Specialists.
• Provide technical oversight of manufacturing and environmental monitoring investigations.
• Drive consistency in root cause analysis and CAPA development.
• Lead cross-functional partnerships across Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development.
• Support and present during regulatory inspections and internal audits.
• Monitor investigation metrics and drive continuous improvement.

Skills

Leadership

Team leadership

Cross-functional collaboration

Environmental Monitoring

Root Cause Analysis

GMP knowledge

Communication skills

Coaching

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Tools

Veeva QMS

Job description

Manager Manufacturing Programs – Investigations

An essential leadership role, you will lead the Manufacturing Investigations team supporting the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will develop a high-performing team that conducts timely, thorough, and compliant deviation investigations while driving operational excellence, inspection readiness, and continuous improvement.

What you will do

• Lead, develop, coach, and mentor a team of Manufacturing Investigation Specialists specializing in simple deviation and environmental monitoring investigations.
• Apply advanced understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.
• 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.
• Manage team priorities, workload balancing, resource planning, and performance management.
• Provide technical oversight of manufacturing and environmental monitoring investigations.
• Drive consistency in root cause analysis and CAPA development.
• Serve as site subject matter expert for Environmental Monitoring related investigations.
• Lead cross‑functionnal partnerships across Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development.
• Lead escalation and governance for deviations.
• Support and present during regulatory inspections and internal audits.
• Monitor investigation metrics and drive continuous improvement.
• Champion Operational Learning Team principles and organizational learning.
• Develop investigation procedures, standards, and training.
• Build a culture of accountability, inclusion, and operational excellence.

What we expect of you

The collaborative leader we seek has extensive biologics drug substance manufacturing experience with demonstrated success leading technical teams, driving cross‑functional collaboration, and improving quality systems.

Basic Qualifications

• Doctorate degree
• Master's degree and 3 years of directly related experience
• OR Bachelor's degree and 5 years of directly related experience
• OR Associate's degree and 10 years of directly related experience
• OR High school diploma/GED and 12 years of directly related experience
• Minimum one of the above qualifications and experience directly managing people and/or leading teams, projects, programs, or directing the allocation of resources.

Preferred Qualifications

• 5+ years of biologics manufacturing, microbiology, quality, or related pharmaceutical experience.
• 0-2 years of people leadership or technical leadership.
• Strong knowledge of GMPs, contamination control, and environmental monitoring.
• Expertise leading investigations and root cause analysis.
• Degree in Science or Engineering (Microbiology or similar a plus).
• Experience with Veeva QMS or equivalent quality systems.
• Experience supporting FDA and global regulatory inspections.
• Strong communication, coaching, and organizational leadership skills.

Compensation and Benefits

The annual salary range for this opportunity in the U.S. is [HR to input market pay range].

In addition to base salary, Amgen offers a comprehensive Total Rewards package including health and welfare benefits, retirement savings, annual bonus opportunity, stock-based long‑term incentives, generous paid time off, company shutdowns, and career development opportunities.