Quality
Associate Director Quality Assurance
Amgen Singapore Manufacturing
HOW MIGHT YOU DEFY IMAGINATION?
Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an Associate Director Quality Assurance in Amgen Singapore Manufacturing.
What you will do
Responsible for providing oversight and leadership for Quality on-the-floor and functional area support, the Assoc Dir Quality Assurance will support all direct manufacturing.
The role involves leading and guiding a team of FTEs, trainees and a number of CW Staff. The areas of responsibility include projects, quality oversight of day-to-day activities, deviations, CAPAs and Change Controls and managing Subject Matter Experts responsible for key Quality Management Systems such as Deviations/CAPAs, Change Controls, Quality Risk Management and Document Management System.
Main Responsibilities:
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
Doctorate degree and 2 years of directly related experience OR
Master’s degree and 6 years of directly related experience OR
Bachelor’s degree and/or 8 years of directly related experience AND
Good understanding of IS system compliance with hands on experience of Computer System Validation or Compliance
10 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
Direct experience with bulk manufacturing of biopharmaceuticals preferred.
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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