Zena Kaufman ZGK Quality Consulting

Ms. Kaufman is a global quality systems senior executive in the pharmaceutical and medical devices industries with 25+ years of site-based and corporate experience. She has deep expertise in creating Quality strategies to move sites from unacceptable (e.g., OAI) to acceptable (e.g., VAI status); in implementing effective Quality and Compliance initiatives to support business processes; and in developing transparent processes for communicating with key global regulatory agency worldwide for both devices and drugs.

As SVP of Global Quality at Hospira, Inc., Ms. Kaufman evolved the Company from a compliance to a quality-focused mindset and then to a quality culture, returning sites to acceptable quality status. The Quality Strategy she developed and implemented achieved sustainable compliance and ensured a balance between supply of critical products and remediation. She created cross-functional working teams aligned by topics to expedite addressing emerging issues and promoted their full understanding of global regulatory standards/expectations/requirements, leading to proactivity to compliance at all sites. She created new processes that enhanced enterprise-wide quality, improved risk mitigation and decision making, established robust auditing programs, and implemented numerous cost-savings projects which improved both compliance and supply.

Before joining Hospira, Ms. Kaufman worked in several executive leadership positions at Abbott Laboratories, the last as Divisional VP, Global Quality Systems, Global Pharmaceutical Operations (GPO). In this role, she ensured rapid communication of Quality issues across all GPO sites, and facilitated senior leadership reviews and faster and better-informed decision making. In a previous Divisional VP position, she oversaw Quality Operations for sites supplying US markets located in North America, Puerto Rico and Ireland, post market surveillance, labeling, Third Party Manufacture support for US-supplied product, and management reviews. Serving as Divisional VP of the Quality Center of Excellence, she directed a team that liaised between the external environment and the internal divisional areas. During this time, she was the chair of the PhRMA Technical Leadership Committee and served on the ICH topic group for ICH Q10: Pharmaceutical Quality Systems.

Previously, Ms. Kaufman served in several quality operations, auditing and documentation executive positions at Pfizer/Pharmacia/Searle. She also worked for the Office of the VP for Research at Northwestern University, at SoloPak Pharmaceuticals, and at Wesley-Jessen, a Schering Corp. division.

Ms. Kaufman earned an M.S. in Marine Environmental Sciences from SUNY at Stony Brook, NY, and a B.S. in Biology (Chemistry minor) cum laude, from Queens College, CUNY, New York City.

She is a member of numerous professional organizations, has been a trainer for multiple years on Quality Systems tools training for the FDA Pharmaceutical Inspectorate, co-chaired the 2008 FDA/PDA Quality Systems conference held in US, Europe and China with key regulators, and was a speaker and part of the organizing committee for the 2011 FDA/EMA/ISPE/PDA Q10 conference.