QA Manager: Lead Quality, Elevate Patient Safety

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 120,000 - 170,000; Full time

Job summary

Amgen in Ohio is seeking a Manager, Quality Assurance to lead quality teams, drive a culture of quality, and ensure product safety and regulatory compliance. The role oversees deviations, CAPAs, change controls, validation, and documentation, while partnering across Manufacturing, QC, and Supply Chain to deliver compliant, high-quality medicines.

The position requires advanced degrees with leadership experience in a GMP-regulated environment, and offers a comprehensive benefits package and

Qualifications

• Doctorate, Master’s, Bachelor’s, or equivalent in Life Sciences, Engineering, or related field.
• Experience directly managing people and leading teams, projects or resources.
• Understanding of GMP, GDP, and regulatory expectations.

Responsibilities

• Lead, coach, and develop Quality staff across assigned areas and shifts.
• QA oversight of manufacturing packaging to ensure compliance with cGMP, GDP, and global regulatory requirements.
• Ensure facilities, equipment, processes, materials, and products meet quality standards.
• Review, approve, and oversee Deviations, CAPAs, Change Controls, and validation documentation.
• Drive investigations and resolution of deviations with timely, compliant outcomes.
• Ensure production records and test results are inspection-ready.
• Champion continuous improvement to strengthen quality systems and operations.
• Partner cross-functionally with Manufacturing, QC, Engineering, and Supply Chain.
• Assess and manage quality risks; escalate issues to senior leadership as needed.
• Represent QA during audits and inspections; support audit readiness.

Skills

Leadership experience

Quality Assurance

cGMP knowledge

Regulatory compliance

Investigations

Education

Doctorate degree

Master's degree

Bachelor's degree

Associates degree

High school diploma

Job description

Amgen in Ohio is seeking a Manager, Quality Assurance to lead quality teams, drive a culture of quality, and ensure product safety and regulatory compliance. The role oversees deviations, CAPAs, change controls, validation, and documentation, while partnering across Manufacturing, QC, and Supply Chain to deliver compliant, high-quality medicines.

The position requires advanced degrees with leadership experience in a GMP-regulated environment, and offers a comprehensive benefits package and