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Associate Director Quality

3 months ago

Singapore Amgen Full time

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 in Amgen Singapore Manufacturing .

Associate Director Quality

Live

What you will do

Main Responsibilities:

  • Accountable for Quality oversight of incoming raw materials and components

  • Accountable for oversight of raw material and consumable sampling for inspection and testing

  • Accountable to oversee identify testing performed by incoming raw material team

  • Accountable for Quality oversight of external warehouses

  • Accountable for external service provider oversight of those supporting incoming raw materials and consumables

  • Oversees and controls the disposition of product and Raw Materials through review and approval of all required disposition documents

  • Reviews all the elements, data and report of the disposition packet

  • Authorized to determine product disposition (Release or Reject) status

  • Approves the disposition packet

  • Performs comprehensive quality assessment to determine and make the usage decision

  • Confirms that the product and Raw Materials meets all Amgen internal requirements

  • Confirms that the product and Raw Materials meets all quality specifications

  • Performs disposition of terminated batch, as applicable

  • Represents disposition process and execution during regulatory inspections

  • Participates in quality projects as required

  • Completes required assigned training to permit execution of required tasks

  • Alerts Senior management of significant quality, compliance, supply and potential product safety risks

  • Supports Continual Improvement initiatives, programs and projects

  • Provide assessment to Change Control pertaining to Disposition Dependent Task

  • Provide input/ advises to Deviation Owner and QA contact related to Disposition

  • Ensures that Disposition personnel are qualified and trained to perform assigned functions in accordance with cGMP with requirements, as applicable

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.

Win

What we expect of you

Qualifications

  • 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

Your selection for this role will may be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Thrive

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.

  • Vast opportunities to learn and move up and across our global organization

  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

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

Equal Opportunity Statement

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.