Tracy Guldan MA Civica Rx

Tracy Guldan is a global quality and compliance executive with over 30 years in industry, most notably at Amgen, Novartis, J&J, and Civica Rx. She has led quality organizations across the pharmaceutical lifecycle from translational science to last mile shipping. She has worked at greenfield facilities, done Warning Letter remediation, and turned around struggling teams. She has worked under the extreme pressure of four pandemic vaccines - H1N1 and Covid vaccine at three companies, using her commitment to patients and her sense of humor to cope with the stress. Through two international assignments in China and experience as a global auditor, she has seen the very best in our industry as well as things that have caused her to lose sleep. Tracy holds deep values of making an impact by supporting a strong quality culture where patients are always at the forefront and quality is seen as financial asset; empowering world class quality teams that acts as business partners and not the police; and building the next generation of leaders to ensure a safe and reliable drug supply for the future. Tracy is currently the Head of Quality Systems at Civica Rx, an organization that aligns well with her values.