Manager PQA

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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 its 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.

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

Lead Quality. Inspire Excellence. Impact Patients.

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

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.

• Doctorate degree
• Masters degree and 3 years of quality experience
• Bachelors degree and 5 years of quality experience
• Associate degree and 10 years quality experience
• High school diploma / GED and 12 years of quality experience

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

• Bachelors degree in Life Sciences, Engineering, or a related field (advanced degree a plus)
• 3+ years of experience in Quality Assurance within a GMP‑regulated environment (biotech/pharma preferred)
• Prior leadership or people management experience strongly preferred
• Deep knowledge of cGMP, GDP, and regulatory expectations
• Proven experience with quality systems (deviatio…