Committee & Presenter Biographies

Denyse Baker is the Associate Vice President, External Engagement and Advocacy, for the Global Quality Compliance organization at Eli Lilly. She is passionate about connecting and collaborating to develop science-based regulation and organizational quality culture as to enable production of high quality products for patients. Denyse has a strong technical foundation to her policy work with experience in engineering, manufacturing, quality and regulatory for small molecules, biologics and devices. Denyse returned to Lilly in December 2022 following work experience with the US FDA, the Parenteral Drug Association, and AstraZeneca. She is a member of the Global Quality Management WG at PhRMA, Vice-Chair of PDA’s Regulatory and Quality Advisory Board, Co-leader of the PDA Quality Management Maturity Task Force, and secretary to the FDA Alumni Association Board of Directors. Denyse holds a B.S. in Mechanical Engineering from Northwestern University, is a licensed professional engineer, and earned RAC certifications in US and EU Reg Affairs.

I am currently a Senior Consultant with InterPro QRA, providing technical services and CGMP guidance to the pharmaceutical industry. In 2012, I completed 14 years of service with the USFDA as a Senior Policy Advisor and Compliance Officer in the International Compliance Branch at CDER Office of Compliance. I also served as the Drug Specialist and a Consumer Safety Officer in the Baltimore District. I was a member of the International Inspection Cadre since 2001, and I have conducted inspections and audits of pharmaceutical manufacturers throughout North and South America, Europe, Asia, and Australia.

I graduated from Virginia Polytechnic Institute & State University with a B.S. in Science of Food, Nutrition, and Exercise (Pre-Med). I served three years on Active Duty in the U.S. Army.

Nicole Deschamps, PhD is a Senior Director, Strategic Product Quality at GSK where she provides leadership for Product Quality leads, end-to-end product quality leadership and oversight for small molecule and biopharm programs throughout product and process development, technology transfer, commercialization, and major lifecycle changes. Nicole has a PhD in Chemistry and started her career at GSK in 2007 in process development where she specialized in the application of laboratory automation tools, advanced manufacturing technologies, Quality by Design, and continuous improvement. In her current role, Nicole has the privilege of collaborating within dynamic cross-functional teams to deliver new life-saving medicines to patients, often via accelerated regulatory approval pathways, new manufacturing technologies such as continuous manufacturing, and lifecycle changes for critical products to continuously improve and ensure compliant and robust supplies of product to our patients. Nicole lives in North Carolina with her husband, two teenaged children and pet dog. She can often be spotted cheering on her kids at the soccer fields, hiking, and walking the dog. She now considers her kitchen to be her lab and loves to cook and garden.

Irving Ford is currently the VP of Quality at Adaptimmune and has over 29 years of QA/QC experience in pharmaceutical/biotechnology and cell/gene therapies industries.

Prior to joining Adaptimmune, Irving was a significant contributor for activities supporting the regulatory filings and commercial approval of BMS’ CAR T products Abecma and Breyanzi as well as Novartis’ CAR T product Kymriah.

Irving is an active member of PDA and has served on several planning committees for various PDA Conferences. Irving is a co-author of PDA TR-13- EM of Low Bioburden Facilities, PDA Points to Consider for ATMPs, and for the published White Paper – Risk Assessment Approach to Microbiological Controls of Cellular Therapies.

Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action decisions relating to manufacturing site acceptability, and promoting sound regulatory policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.

Ray Gaines is the Branch Chief of Global Compliance Branch 3 in CDER’s Office of Compliance, Office of Manufacturing Quality, Division of Drug Quality I. He has a background in chemistry and over 29 years’ experience between industry and FDA. He started his career as a chemist in a global pharmaceutical company in an R&D lab and moved to plant quality compliance and later managed global contract manufacturers. He was involved with due diligence audits, new business development, and quality and compliance activities. Ray joined FDA in 2011 as an Interdisciplinary Scientist and has also served as a Team Leader. As Branch Chief he oversees the review of violative (OAI) facility inspection reports. Ray holds BS degrees in Chemistry and Biology from Virginia Commonwealth University.

Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 25 years in the pharmaceutical industry, in various microbiology and management roles. In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.

He has been an active PDA member for over 20 years and is presently serving on the Board of Directors, both the Science and ATMP Advisory Boards and is the co-chair of the Microbiology/EM Interest Group. Marc is also co-chairing the Microbial Data Deviation Investigations conference and participating on the planning committee for PDA/FDA and Global Microbiology conferences. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and is currently supporting multiple PDA global chapters.

In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA’s Training and Research Institute, and the 2023 Michael Korczynski Award for his work with PDA’s international chapters.

Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University.

CAPT Tara Gooen Bizjak is the Director of the Manufacturing Quality Guidance and Policy Staff in CDER, Office of Compliance, Office of Manufacturing Quality and is an engineering officer in the United States Public Health Service.  Tara has been with the FDA for 20 years and has focused in the area of drug manufacturing, current good manufacturing practice (CGMP) inspections, and related policy.  She started as a field investigator in the New Jersey District and transferred to CDER in 2007.  Prior to her current role, she was a senior science policy advisory in the Office of Pharmaceutical Quality in the area of quality metrics and emerging technology, branch chief in the area of drug manufacturing pre-approval inspections and a senior advisor in the Office of Regulatory Affair’s Office of Policy and Risk Management.  CDR Bizjak is an ASQ (American Society for Quality) Certified Quality Engineer and Quality Improvement Associate.  She received a B.S. in Chemical Engineering from Cornell University and a Masters in Biomedical Science from Rutgers University.

Sharyl Hartsock began her 34-year pharmaceutical career with Eli Lilly and Company, where she held various quality leadership roles supporting both parenteral and medical device manufacturing. Through the years, she developed a deep operational understanding of quality systems and aseptic processing needed to ensure sustained regulatory compliance and patient safety. This foundation enabled transition into an enterprise role as the Associate Vice President of Global Quality Systems. In this role, Sharyl had primary responsibility for establishment and maintenance of the enterprise Quality Management Systems, oversight of global M&Q data management, and administration of Information Systems Quality. In her current role as Vice President, US Parenteral Quality, she has primary oversight for the new parenteral manufacturing, device assembly and packaging sites in Durham and Concord, North Carolina. Ms. Hartsock received her BS degree in Pharmacy from Butler University in 1989.

Ingrid Markovic, Ph.D. is Senior Science Advisor in the FDA/CBER Immediate Office of the Center Director, where she is responsible for providing leadership, strategic roadmap and guidance for development, implementation and integration of CMC policies for biological and biotechnological products.In this role, she forms key strategic partnerships ensuring consistent interpretation and application of CMC policies accross, and between, Centers.

In the international arena, Ingrid serves as CBER ICH Quality Lead. She is/was FDA topic co-lead for Q12, QDG, and, most recently, M4Q. She had an opportunity to briefly serve as ICH Q3E Rapporteur. Prior to her current role, Ingrid worked in the industry sector leading US & EU CMC Reg Policy efforts focusing on Technological Innovation and Cell & Gene Therapies. She collaborated with Trades Associations supporting continual improvement and innovation in the Biopharmaceutical sector.

Ms. Skutnik is the Director of Regulatory Surveillance in Global Quality at Moderna. Her former positions include: Director, Global Regulatory CMC Regulatory Intelligence at Biogen, Association Director, Quality Intelligence at Biogen, Vice President at NSF DBA, Director /Team Leader of Quality & Regulatory Policy at Pfizer. In these roles she was responsible for working with trade associations and developing company positions on Quality and CMC issues, monitoring global regulations/guidelines/standards. She has over 28 years experience in compendial activities, quality and regulatory policy, and has held a variety of positions with responsibilities in documentation, change control, analytical method validation and product launch. Ms. Skutnik earned a Bachelors of Science from the University of Connecticut in 1994. She served on PDA's RAQAB, and is the co-chair of PDA's Pharmacopoeial IG. She is a member of the ICH IWG for ICH Q3D Elemental Impurities, and was on the EWG for Q3D. She was the Chair of PhRMA’s Compendial Liaison Team (2000-2012); and the PhRMA Topic Leader for the ICH Topic – Q4B. She was the chair of the IPEC organisation twice, and was also president of the IPEC Federation. She is the IPEC Delegate to the ICH Assembly and ICH Informal Quality Discussion Group.

Jackie has many years of experience within pharmaceutical quality across the product life cycle. Her experience includes site head quality, R&D quality lead and corporate/divisional quality roles within quality systems. She has worked at large and small pharmaceutical companies including Pfizer, Abbott/Abbvie and Celgene.  She led the global Data Integrity team at Celgene developing and implementing DI policies, procedures and training. Her current role is with Legend Biotech leading Global Quality Systems and Compliance.  In addition, Jackie is the Chair of the Regulatory Affairs and Quality Advisory Board (RAQAB) at PDA and leads the Data Integrity Interest Group. She was also involved in the Data Integrity Q&A document on inspections and is currently involved in the Technical Report for Data Integrity in Quality Management Systems.

Valerie assumed the role of Vice President Quality in January 2022 with responsibility for the Quality oversight of all Drug Substance manufacturing sites within the Thermo Fisher Scientific manufacturing network.

Immediately prior to this Valerie was the Head of Quality Operations for Amgen where she had Quality oversight for Amgen's internal manufacturing network, Digital and Data Science Quality and the Quality Control Network. R&D with responsibility for Quality, Compliance, Audit, Computer Related Systems and Learning & Performance across all aspects of Amgen’s Research & Development activities.

Previously, at Amgen, Valerie has held the roles of Head of Quality and Compliance for R&D, Head of Corporate Quality and roles as Site Quality Head for the ATO Manufacturing Site and the Amgen site in Dun Laoghaire, Ireland. Prior to joining Amgen in 2011, Valerie held a variety of roles of increasing responsibility within the Quality functions of Pfizer, Bimeda and Takeda.

Valerie is a Microbiologist and Qualified Person and has over 20 years’ experience in the industry covering a diverse range of pharmaceutical and biotechnology areas both in Europe and the US.