Amgen Manager QA in Hong Kong, Hong Kong
Quality Manager - International Distribution Quality (Quality Lead for clustered countries, including Hong Kong, Macau, Vietnam and Philippines)
Roles and Responsibilities
Clustered Country Quality Lead of Hong Kong, Macau, Thailand, Vietnam and Philippines.
Responsible to maintain and implement an effective quality management system that meet local regulatory requirements on Good Distribution Practices.
Manage and maintain wholesale, import license of Amgen’s product in applicable countries.
Quality Contact to review and approving quality related records (including change controls, deviations, CAPA etc.)
Responsible to perform product disposition activities of Amgen Hong Kong affiliate and collaborate closely with cross-functional team to ensure successful product launches and continuous supply of products.
Third party quality oversight and distribution operational activities (e.g. due diligence evaluations, audits and inspections, complaints management, quality agreements, Key Performance Indicator monitoring, quality related training etc.) across approved distributors, logistic service providers (LSP) and suppliers for those clustered countries.
Responsible to ensure initial and continuous training programs are implemented and maintained in a state of compliance.
Responsible to coordinate and perform any recall operations in collaboration for Recall Task Force Executive Committee. Lead annual mock recall audits in clustered countries in scope.
Ensure that customer complaint are dealt effectively according to internal Amgen procedural requirements.
Ensure that suppliers and customers are legally approved or authorized to enable lawful supply of products.
Responsible to approve subcontract activities to meet the Good Distribution Practice requirements.
Responsible to ensure that self-inspections are performed at appropriate regular intervals according to approved plan and necessary CAPA responses are implemented in a timely and compliant manner.
Responsible to approving any returns to saleable stock and ensure that any additional requirements imposed on certain products by national legislation are adhered accordingly.
Bachelor’s Degree and at least 8 years of Quality Assurance experience
English language fluency
Experiences with commercial quality operations and third party LSP/distributor management
Experiences with quality management systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections; prior working experiences as Person-In-Charge of WDL license in Hong Kong
In-depth knowledge and experiences of Good Distribution Practices
Strong organizational skills and ability to manage multiple tasks at one time, including the ability to follow assignments through to completion and meet timelines (commitment to task, attention to detail)
Strong communication skills, both written and oral
Demonstrated ability to work as both a team player and independently
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.