Quality Assurance Manager (Excellence & Innovation)

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 a Quality Assurance Manager (Excellence & Innovation) in Amgen Singapore Manufacturing.

Live

What you will do

• This role shall reports to Site Quality Head.

• Act as site SME and business process owner for training and Learning Management System and represent Singapore site in the Learning and Performance global network

• Lead and mentor staff in Team

• Support SME and Functional Area Managers as clients of training process, provide infrastructure for training material development and effective deployment and monitoring

• Plan, coordinate, implement and monitor GMP training programs and initiatives

• Assist in investigations and CAPAs by identifying human performance factors and improvement opportunities

• Provide Training impact and assignment requirements to SOP revisions and Change Controls

• Represent Training program in internal and external inspections representing areas of responsibility. Ensure training records are accurate and readily available during inspections

• Ensure training related metrics and KPIs are monitored and analyzed for site management review and corporate management reviews

• Manage New Hire Orientation training and scheduling

• Support Quality Systems activities

ASM Quality Strategic Planning & Governance

• Partner with ASM Quality leadership to define and execute strategic priorities.

• Coordinate governance forums and ensure timely follow-up on goals and other action items.

ASM Quality Operational Excellence

• Drive initiatives related to Safety, Quality, and Compliance as foundational priorities.

• Govern, Drive and Monitor progress on ASM Quality ideation and projects. Represent ASM for Quality CI and AI network.

• Ensure key performance metrics are monitored at Site QLT level for early identification of risks and weak signals.

• Champion initiatives under Continuous Improvement + AI and Digital projects.

Cross-Functional Collaboration

• Act as liaison between Quality sub-functions (QA, QC, MSQA, Compliance/QMS) and other site functions.

• Support talent retention and staff development processes for ASM Quality.

ASM Quality Communication & Engagement

• Prepare dashboards, and presentations for internal and external stakeholders.

• Champion initiatives to promote staff engagement programs.

• 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 OR

• Master’s degree and 2 years of directly related experience OR

• Bachelor’s degree and 4 years of directly related experience

• Diploma and 8 years of directly related experience

• The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent

• 8+ years of experience in the pharmaceutical industry

• Training experience in GMP environment preferred

• Proven leadership in cross-functional project management and strategic planning.

• Strong communication, influencing, and stakeholder management skills.

• Familiarity with compliance frameworks (EMA, HSA, FDA) and GMP standards.

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.