QA Manager: Lead Quality & Compliance in Biotech

Amgen; New Albany (OH); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Discretionary annual bonus

Flexible work models

Job summary

Amgen is seeking a Manager, Quality Assurance at our Ohio site to lead QA staff, shape quality culture, and ensure safe, effective therapies reach patients. The role focuses on QA governance across manufacturing and quality systems with broad cross-functional collaboration.

You will drive continuous improvement, oversee deviations, CAPAs and changes, and prepare for regulatory inspections, while fostering a culture of accountability and excellence.

Qualifications

• Doctorate or Master’s/Bachelor/Associate with required years of quality experience.
• Experience directly managing people and leadership roles in teams or projects.
• Strong knowledge of GMP/GDP and regulatory expectations.

Responsibilities

• Lead Quality staff across assigned areas and shifts.
• QA oversight of manufacturing packaging to ensure CGMP/regulatory compliance.
• Manage deviations, CAPAs, change controls, validation documentation.
• Drive investigations and ensure timely, compliant outcomes.
• Represent QA during internal and external audits and inspections.

Skills

Leadership

People management

Quality mindset

Communication

Education

Doctorate degree

Master’s degree with 3 years quality experience

Bachelor’s degree with 5 years quality experience

Associate’s degree with 10 years quality experience

High school diploma / GED with 12 years quality experience

Job description

Amgen is seeking a Manager, Quality Assurance at our Ohio site to lead QA staff, shape quality culture, and ensure safe, effective therapies reach patients. The role focuses on QA governance across manufacturing and quality systems with broad cross-functional collaboration.

You will drive continuous improvement, oversee deviations, CAPAs and changes, and prepare for regulatory inspections, while fostering a culture of accountability and excellence.