Specialist QA I

Specialist QA - QMS
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 Specialist QA - QMS in Amgen Singapore Manufacturing.
Specialist QA - QMS

Live
What you will do
Responsible for assigned Quality Management Systems (Deviation/CAPA and Document Management System). A Subject Matter Expert (SME) and site representative for Amgen Singapore Manufacturing in Amgen Network for the specified Quality Management System. In case of any system update, new system rollout act as the site project lead
Main Responsibilities:
•    Represents site challenges, audit findings, and best practices in collaborative network meetings.
•    Reviews and refines Global Standards, and may author or meticulously quality-check process documentation and training materials.
•    Facilitates the onboarding of new users, providing dynamic training and acting as a coach/mentor within learning groups.
•    Identifies and raises performance trends to Global Process Owners and site/functional/regional management.
•    Ensures robust inspection readiness and aligns local procedures meticulously with QMS requirements.
•    Acts as the primary liaison during audits and regulatory agency inspections, showcasing process compliance and excellence.
•    Collaborates closely with Global Process Owners to fulfill commitments post-regulatory inspections.
•    Actively participates in progressive process improvement initiatives initiated by Global Process Owners or the network.
•    Leads impactful process improvement projects spanning the site/function/region.
•    Takes ownership of site/function deviations, CAPA/EVs, records, ensuring meticulous management and resolution.
•    Develops and champions site/region-specific commitments for process enhancement and sustainability.
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 in Chemistry, Chemical Engineering Science or related technological field and 2 years of directly related experience OR
•    Bachelor’s degree in Chemistry, Chemical Engineering Science or related technological field and 4 years of directly related experience OR
•    Diploma in Chemistry, Chemical Engineering Science or related technological field and 8 years of directly related experience
•    Having related work experience (e.g. manufacturing, process development, or quality assurance) in the pharmaceutical industry with dynamically growing responsibility and demonstrated experience in project management, quality assurance and quality systems
•    Demonstrates exemplary proficiency in written and verbal communication skills, adept at technical writing and delivering compelling presentations to engage both technical teams and senior management.
•    Possesses advanced expertise in assigned quality processes such as Deviation/CAPA and Document Management System, coupled with mastery of relevant IS applications.
•    Maintains a thorough understanding of GxP Regulations and industry standards, ensuring compliance and excellence in quality management.
•    Exhibits robust problem-solving, organizational, and analytical skills, fostering effective decision-making and operational efficiency.
•    Demonstrates influential leadership skills to drive alignment and impact across multiple sites, functions, or regions.
•    Consistent track record in effectively communicating and managing audits and inspections, ensuring adherence to regulatory requirements and continuous improvement.
•    Recognized for leadership in driving transformative change initiatives, fostering innovation and operational excellence.
•    Demonstrates agility and resilience in navigating through ambiguity, providing clarity and direction amidst complexity.
•    Proficient in people management, fostering a collaborative and high-performance culture within teams.

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.