Kim Crahan

About Kim Crahan

Experienced Director of Quality with a demonstrated history of working in a highly…

Experience

1. Associate Director, Regulatory Compliance

   Grifols

   Jan 2020 — Present

   Promoted to Associate Director after nine months with the Company. Responsible for directing and maximizing operational effectiveness and efficiencies, as well as continuous process improvement activities. Works closely with Senior Director to drive and execute overall strategy for Global Plasma Regulatory Affairs. Serves as a liaison with various Regulatory Agencies both European and Domestic. Directs and oversees internal and external regulatory compliance objectives within entire company to ensure inspection readiness, including related projects and continuous improvement. Manages and oversees the Data Integrity program within the company to ensure compliance with regulatory requirements. Directs and oversees activities required to ensure Plasma donor center and plasma facilities\' inspection readiness and subsequent compliance with Domestic (FDA, CLIA/COLA, PPTA, AABB, State), ICH, ISO, Health Canada, European (EU) and ROW (Rest of World) regulations. Including management of the Plasma Master File, in collaboration with the Parent Company. Responsible for the management and oversight of the internal audit program, which includes internal audits for 300+ plasma centers, corporate operations, plasma testing, warehouse, transportation and other plasma supplier operations to measure compliance with established Standard Operating Procedures, OSHA, CLIA, iQPP, AABB, FACT, FDA regulations, Health Canada, EMA (EU), customer specifications, foreign health authorities, and other state and local regulatory authorities. Also responsible for managing and directing supplier audits for approximately 200 suppliers. Responsible for preparation and maintenance of the budget. Manages 30+ staff.