Amgen Mgr QA in Singapore, Singapore
Quality and Compliance oversight of lower risk External sites. Ensure External site activities are in alignment with applicable product CTA /Marketing Application.
Serve as the main Quality point of contact related to Amgen product at External site
Manage External site to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements
Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses
Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site
Provide quality oversight of the manufacturing, testing, and release of Amgen products at External site
Author and drive actionable site inspection readiness plans
Author inspection playbooks with External site on key risks/gaps and drive readiness efforts with External site
Representation at Amgen product-specific Regulatory Inspections and/or during Notified Body audits of External site, as applicable or required
Identify and mitigate risk at the External site
Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews
Escalate risks or roadblocks to management
Drive timely decision making using DAI principles
Drive continuous improvements and Amgen first mindset
Perform tactical batch disposition activities in support of lot release
Doctorate degree in Science and 3 years of directly related experience
Master’s degree in Science and 5 years of directly related experience
Undergraduate degree in Science and 8 years of directly related experience
Undergraduate diploma in Science and 10 years of directly related experience
Fluency in written and spoken English
8 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.
Managerial and 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
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.