Gregory L. Tewalt, PhD Kaleo, Inc.

Gregory Tewalt has over 30 years of experience within pharmaceutical, biopharmaceutical, and drug/device combination product organizations worldwide.  He led company and divisional technical and quality strategy to include: developing laboratory and manufacturing system commissioning, qualification and validation practices for clinical and commercial small and large molecules aligned with industry standards and regulations; actualizing initiatives for a new CMO to establish the Quality Management System (QMS), integrating risk management principles to streamline facility and equipment qualification practices; and successfully executing 2011 USFDA Process Validation practices.

Gregory is the Director of Quality Systems and Compliance at Kaleo, Inc. in Richmond, Virginia, where he manages, implements, and maintains kaléo’s QMS for all GxP operations aligned with applicable regulatory, ICH and ISO guidelines and standards. He develops and implements continuous quality system improvements, has redesigned and implemented a robust risk-based supplier qualification program, manages and conducts internal and supplier audits, and ensures inspection readiness at kaléo and all suppliers.

Gregory champions data integrity and quality culture programs within the Development and Operations organization at kaléo; hosting the annual kaléo Quality Summit, which fosters transparent and collaborative partnerships with kaléo suppliers utilizing discussion of current regulatory trends and topics, invited speakers, and group participation exercises.