Manager Quality Assurance - Plant QA

Manager QA (Plant 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 a Manager QA (Plant Quality Assurance- Shift) in Amgen Singapore Manufacturing.

Live

What you will do

Responsibilities:

• Responsible for providing oversight and leadership for Quality on-the-floor and operations support, the Manager Quality Assurance will support manufacturing operations and IPC testing through purposeful presence on the floor, and batch record closure, change controls, and unexpected result investigations. This role will be required to support shift work.
• Provide direct Quality Assurance support for all GMP activities (including on-the-floor quality oversight, batch record closures, deviations closure, change control and CAPAs) at ASM
• Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics
• Perform comprehensive Quality review to support lot disposition of bulk drug substance
• Act as one of the key Quality Contacts to resolve complex issues, adhering to Amgen policies and standards
• Participate in root cause investigations for complex and significant nonconformances, leveraging various root cause analysis tools
• Develop best teams by ensuring that all team members are motivated to work toward common goals and coaching key talents.
• Mentor and coach cross functional team members to establish a quality culture for routine operations
• Develops a continuous improvement framework within the team, identifies and implements projects and improvements, actively supports site improvement programs to increase efficiency, agility, compliance, productivity, and also reduce cycle time, inventory and waste
• Participate in regulatory inspections, and interact directly with regulatory inspectors
• Escalate significant quality issues to Quality management in a timely manner

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 OR
• Diploma and 8 years of directly related experience
• Preferred 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems. Direct experience with bulk manufacturing of biopharmaceuticals/API 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.
• Experience with regulatory audits and inspections
• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality
• Supervisory experience will be an advantage

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

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.

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.