Manager, QA Evening Shift

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this. Lets 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. Were 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, its 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 packagingactivities to ensure compliance with cGMP, GDP, and global regulatory requirements

Ensure thatfacilities, 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 [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 3 years of quality experience

OR

Bachelors degree and 5 years of quality experience

OR

Associates degree and 10 years quality experience

OR

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, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 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
  (deviations, CAPA, change control, validation)

• Strong ability to
  lead in a shift-based operation
  , with flexibility for evenings, nights, weekends, or holidays

• Excellent communication, decision-making, and problem-solving skills

• A proactive, collaborative leader who can
  influence and inspire across functions

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted.…