Our client is looking for a Clinical Quality Manger/Clinical QMS Consultant for a 6+ month contract. This role will help bridge the gap for lack of internal expertise and to harmonize between the Clinical and Quality teams. This individual will be heavily focused on QMS and Doc Management with the Clinical Operations and Development teams, supporting and stabilizing their SOP’s and QMS to help with continuous process improvement efforts and ensure compliance within the respective groups and organization. This person must be a Clinical Quality expert, including extensive QMS and management experience. 10 plus years of pharma industry experience working for sponsor and/or CRO focusing on GCP, Risk Management, Continuous Improvement, QMS (Veeva), and Doc Management. It would be a huge plus for this individual to have some background in Lean Process Improvement or have a Lean certification.
- Education: Experience outweighs degree, no specific requirements
Indianapolis, Indiana: Process Engineers Aseptic Fill Finish (231525)