QA Sr Mgr
About The Position
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 do Let’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.
Requirements
- Doctorate degree and 2 years of experience OR Master’s degree and 4 years of experience OR Bachelor’s degree and 6 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Nice To Haves
- 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.
Responsibilities
- 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.
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
