Sr Manager Quality Assurance, Device Supplier Management and Oversight

Career Category

Job Description

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. 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.

Sr Manager Quality Assurance, Device Supplier Management and Oversight

What you will do

Let’s do this. Let’s change the world. In this vital role you will program manage remediation of assigned critical external mechanical device suppliers.

• Lead a team of quality professionals overseeing external mechanical device suppliers

• Ensure compliance with scientific, regulatory, and quality standards across global operations

• Collaborate cross-functionally with teams in External Supply, Process Development, and Combination Product Quality

• Drive change, ensure product quality, and create a diverse and inclusive environment

• Monitor quality systems and performance of external device suppliers.

• Define and enforce quality requirements

• Manage supplier quality KPIs and risk escalations

• Manage and develop assigned team members

• Work collaboratively with cross functional teams across Amgen

• Lead impactful cross-functional initiatives

• Foster a culture of continuous improvement and operational excellence

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Medical Device, Pharmaceuticals or Biotechnology experience

Or

Master’s degree and 6 years of Medical Device, Pharmaceuticals or Biotechnology experience

Or

Bachelor’s degree and 8 years of Medical Device, Pharmaceuticals or Biotechnology experience

Or

Associate’s degree and 10 years of Medical Device, Pharmaceuticals or Biotechnology experience

Or

High school diploma / GED and 12 years of Medical Device, Pharmaceuticals or Biotechnology experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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

Preferred Qualifications:

• Degree in Biology, Engineering, Pharmaceutics, Biotechnology, or Physics

• 10+ years in Medical Device/Pharma/Biotech sectors

• Knowledge of quality systems (batch release, complaints, risk management)

• Knowledge of global supplier management and device regulations

• Strong leadership, communication, and problem-solving skills

• Experience leading global teams, including during change

• Travel up to 25%, domestic and international

What you can expect of us

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, we’ll 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. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group me