Amgen GCP Compliance Manager in Shanghai, China
•To support objective compliance advice and oversight to the business for GCP activities
•Strengthen and advance Amgen’s R&D QMS
•Improve R&D processes through contribution of expertise in identifying appropriate CAPAs
•Enable timely completion of CAPAs through CAPA status reports
•Identify CAPA trends
Ensure quality of data in RDCS
The role of the GCP Compliance Manager is to support the provision of proactive GCP compliance oversight and guidance to functional areas and stakeholder groups within the R&D organization. Activities are to be performed under supervision of Compliance Senior Manager and/or Director GCP Compliance.
•Entering and updating records in RDCS based on investigation and exception meetings and tracking through to closure
•Supporting GCF Level 6 investigation lead in RCA & effectiveness verification activities of CAPAs
•Collating and verifying objective evidence for inspection & audit-driven CAPAs
•Assessing quality and accuracy of data in RDCS and reporting on RDCS status, progress and activities, as required based on regulations and guidance from GCF Level 6
•Data entry into the risk assessment tool (using risk assessment methodology)
•Support Safety, Global Development and Global Research teams in GCP inspection readiness and inspection management activities
•Support R&D Compliance on governance bodies in the clinical development, pharmacovigilance and/or research area
•Support the GCP compliance team as needed with functional activities including exception management, inspection readiness, administration of compliance committees
•Maintain knowledge of current regulatory and compliance practices/issues
•Collate compliance metrics (e.g. audit/inspection data and other significant compliance information) to support presentations to key stakeholders
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.