QA Leadership Manager: Drive Quality & Compliance

Amgen Inc. (IR); New Albany (OH); On-site; USD 118,000 - 160,000; Full time

Job summary

Amgen Inc. (IR) in Ohio is seeking a Manager, Quality Assurance to lead QA staff, oversee manufacturing packaging quality, and ensure compliance with cGMP, GDP, and global regulations.

You’ll shape quality culture and drive initiatives across functions to deliver safe, effective therapies. You will manage deviations, CAPAs, change control, validation, and document control while partnering with Manufacturing, QC, Engineering, and Supply Chain to maintain inspection readiness and strong quality

Qualifications

• Doctorate degree OR Master’s degree and 3 years of quality experience OR Bachelor’s degree and 5 years quality experience OR Associate’s degree and 10 years quality experience OR High school diploma / GED and 12 years of quality experience
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resources.

Responsibilities

• Lead, coach, and develop Quality staff across assigned areas and shifts
• Provide QA oversight of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements
• Ensure facilities, equipment, processes, materials, and products meet quality and compliance standards
• Review, approve, and oversee QA systems including Deviations, CAPAs, Change Controls, Validation documentation, Procedures and batch records
• Drive investigations and resolution of deviations ensuring timely, thorough, and compliant outcomes
• Ensure production records and test results are accurate, complete, and inspection-ready
• Champion continuous improvement initiatives to strengthen quality systems
• Partner with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders
• Assess and manage quality risks and escalate critical issues to senior leadership
• Represent QA during audits and regulatory inspections; support inspection readiness
• Ensure document control excellence with ownership and timely review of controlled documents
• Foster a culture of quality, accountability, and compliance across teams

Skills

People management

Leadership

Quality assurance

Communication

Problem-solving

Education

Doctorate

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Tools

CAPA systems

Change control

Validation

Job description

Amgen Inc. (IR) in Ohio is seeking a Manager, Quality Assurance to lead QA staff, oversee manufacturing packaging quality, and ensure compliance with cGMP, GDP, and global regulations.

You’ll shape quality culture and drive initiatives across functions to deliver safe, effective therapies. You will manage deviations, CAPAs, change control, validation, and document control while partnering with Manufacturing, QC, Engineering, and Supply Chain to maintain inspection readiness and strong quality