Sr Manager Quality Assurance, Device Supplier Management and Oversight at Amgen
Washington, DC 20004, USA -
Full Time


Start Date

Immediate

Expiry Date

17 Oct, 25

Salary

182031.0

Posted On

18 Jul, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Physics, Pharmaceutics, Batch Release, Pharmaceuticals, Supplier Management, Global Teams, Biology, Biotechnology, Addition

Industry

Pharmaceuticals

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

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
Responsibilities

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
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