Associate Director Quality Assurance

Career Category

Job Description

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.

Live

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:

• Ensuring Quality Assurance support for all ASM1 manufacturing activities (including on-the-floor quality oversight, batch record review, quality records approval)
• Support routine GMP Oversight activities (e.g. SOPs, logbooks, reports) and ensure key performance indicators meet targeted metrics
• Ensure required Quality resources are available to support commercial operations.
• Inspection Readiness and Support
• Participate in root cause investigations for complex and significant exceptions or issues, leveraging various root cause analysis tools
• Support site/network driven QA continuous improvement initiatives/activities
• Escalate significant quality issues to Quality Management in a timely manner
• Act as delegate to Quality Assurance Director when required to support business needs
• Support Drug Substance Alignment Meetings for Functional areas
• Providing guidance to the team
• Mentoring and Decision Making
• Ensuring alignment across the Quality Teams
• Supporting critical deviation resolution
• Ensuring timely closure of Quality records
• Ensuring timely review and approval of documentation
• Supporting the team in critical meetings
• Attend project and strategy meetings
• Meeting with the Functional Area/ Leadership monthly
• Plant QA/Manufacturing Support QA Huddle attendance
• SQDIP attendance ASM1
• Attend the Weekly Operational Meetings for ASM1
• Team one to one meetings
• Weekly Team Meeting
• XLT Meeting attendance
• Schedules tasks and ensure a level workload for the team
• Training oversight

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

Basic 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 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

Your selection for this role will 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.