QA Manager: Lead Quality & Compliance (GMP)

BioSpace; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, and vision coverage

Disability insurance

Stock-based incentives

Bonus program

Job summary

Amgen’s Ohio site seeks a Manager of Quality Assurance to lead quality teams and drive a culture where quality is a mindset. You will oversee manufacturing packaging QA, deviations, CAPAs, and change controls, ensuring product quality and patient safety.

You will partner cross-functionally and lead continuous improvement initiatives, while ensuring audit readiness and regulatory compliance. This is a dynamic leadership role in a global biotech environment.

Qualifications

• Doctorate degree required; advanced degree preferred.
• Masters degree with 3+ years QA experience or a Bachelors with 5+ years QA experience.
• Multiple pathways shown: doctorate/masters/bachelors/assoc/high school with progressive QA leadership exposure.

Responsibilities

• Lead quality staff across assigned areas and shifts.
• Provide QA oversight of manufacturing packaging to ensure cGMP and regulatory compliance.
• Oversee deviations, CAPAs, change controls, validation docs and batch records.
• Drive investigations, ensure timely, thorough resolutions and inspection readiness.
• Champion continuous improvement to strengthen quality systems and operational performance.
• Collaborate with Manufacturing, QC, Engineering, Supply Chain and other functions.
• Escalate quality risks to senior leadership as needed; participate in audits and inspections.

Skills

Leadership

Quality Assurance

cGMP knowledge

Regulatory understanding

Audit readiness

Education

Doctorate degree

Masters degree

Bachelor's degree

Associates degree

High school diploma

Job description

Amgen’s Ohio site seeks a Manager of Quality Assurance to lead quality teams and drive a culture where quality is a mindset. You will oversee manufacturing packaging QA, deviations, CAPAs, and change controls, ensuring product quality and patient safety.

You will partner cross-functionally and lead continuous improvement initiatives, while ensuring audit readiness and regulatory compliance. This is a dynamic leadership role in a global biotech environment.