Associate Director Quality

at  Amgen

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.

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

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.