Manager, QA Evening Shift

Manager, Plant Quality

Let's do this. Let's change the world. At Amgen, our mission to serve patients drives everything we do. At our Ohio site, we are building a culture where quality is not just a function—it's a mindset. We're seeking a Manager, Quality Assurance who is passionate about leadership, thrives in a dynamic environment, and is ready to make a tangible impact on product quality and patient safety.

This is more than a role, it's an opportunity to lead from the front, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide.

Lead Quality. Inspire Excellence. Impact Patients.

As a QA Manager, you will lead and elevate quality performance while providing strategic and operational oversight across manufacturing and quality systems.

Key responsibilities include:

• 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 that facilities, equipment, processes, materials, and products meet all applicable quality and compliance standards
• Review, approve, and oversee key quality 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 and lead continuous improvement initiatives to strengthen quality systems and operational performance
• Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders
• Assess and manage quality risks, escalating critical issues to senior leadership as needed
• Represent QA during internal and external audits and regulatory inspections
• Support audit readiness and participate in inspection management activities
• Ensure document control excellence, including ownership and timely periodic review of controlled documents
• Foster a culture of quality, accountability, and compliance across all teams

Apply now and make a lasting impact with the Amgen team.