QA Sr Mgr

Career Category Quality 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. 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.

QA Senior Manager What you will doLet’s do this. Let’s change the world. In this vital role you will leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

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.

Key Responsibilities Supplier Oversight:

Monitor quality systems and performance of external device suppliers.

Define and enforce quality requirements.

Manage supplier quality KPIs and risk escalations.

Team Leadership:

Manage and develop assigned team members

Work collaboratively with cross functional teams across Amgen Tactical  Execution:

Lead impactful cross-functional initiatives.

Foster a culture of continuous improvement and operational excellence.

What we expect of youWe 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 and 2 years of experienceORMaster’s degree and 4 years of experienceORBachelor’s degree and 6 years of experienceORAssociate’s degree and 10 years of experience ORHigh school diploma / GED and 12 years of experience

Preferred Qualifications:

Degree in Biology, Engineering, Pharmaceutics, Biotechnology, or Physics.
10+ years in Medical Device/pharma/biotech sectors.

Extensive knowledge of:

Quality systems (batch release, complaints, risk management).Global supplier management and device regulations.

Strong leadership, communication, and problem-solving skills.

Experience managing global teams, including during change.

Travel up to 25%, domestic and international.

What you can expect of usAs 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  addition to the base…