Celia B.

Background

About Celia B.

Accomplished quality, program, project, and alliance management professional, with over 17 years of experience in the life science industry including leading geographically dispersed teams, off-shore resources, and third-party contractors / consultants • Strong understanding of GXP (cGMP, GCP, GLP, GCLP, and GDP), 21CFR Part 11, 210, 211, 820, and ICH Guidelines • Skilled in the use of Operational Excellence (OE) principles including but not limited to Lean, Six-Sigma, Gemba Walks, Value Analysis and Value Stream Mapping • Strong leader with demonstrated track record in managing global teams / stakeholders and PMOs, delivering results in strategy development, M&A, integrations, business process improvement, new product development, and corporate governance • Experience working on Module (3.2.S and 3.2.P) of IND and BLA • Highly organized and thrive in a dynamic environment with tight deadlines and exciting opportunities • Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization; Able to get things done without formal authority • Can effectively drive discussions and decisions toward desired results within and outside of the project team • Strong understanding of Change Management and the ability to develop team members into Change Agents • Expert in MS Project and Visio and advanced skills with MS Office Applications (MS Word, Excel, Access, Publisher, One Note, and Powerpoint) and JMP • Advanced skills with web and video conferencing (WebEx, MS Teams, GoToMeeting, Live Meeting, Zoom, and Skype Business)