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Committee & Speaker Biographies

2020 PDA Board of Directors and Officers Election

Officer Candidates

Susan Schniepp
Susan Schniepp
Chair-Elect

Susan Schniepp has 40 years of quality assurance experience in the pharmaceutical industry. She served in leadership roles at Allergy Laboratories, Inc.; OsoBio Pharmaceuticals, LLC; Searle; Abbott; and Hospira. She has earned several awards from PDA, including its Distinguished Author Award, Distinguished Service Award, and Gordon Personeus Award.

Sue’s publications include the book, Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, for which she was awarded the 2007 PDA’s Distinguished Author Award. She co-edited and contributed to the books Pharmaceutical Outsourcing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers.

Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011- 2013 and from 2016- 2019. Sue has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working part of the working group writing a technical report relating to manufacturing data integrity issues and participating in PDA’s standard setting activity regarding purchasing controls.

In addition to her PDA activities, Sue is an editorial advisory board member and columnist for Pharmaceutical Technology (since 2007) and BioPharm International Magazines. She holds a Bachelor of Science degree in Microbiology from Northern Illinois University.

Glenn Wright
Glenn Wright
Treasurer

Glenn E. Wright is currently the Head of Quality at Exelead Biopharma, responsible for all Quality operations. The company specializes in complex formulation and filling of sterile injectable orphan drug products with a focus on pegylated enzyme and liposomal/lipid-based mRNA and small molecule formulations. Glenn has more than 25 years of experience in the pharmaceutical industry. Previously, he served in various technical and senior leadership positions at Eli Lilly, Amgen, and Pfizer. He has extensive technical, regulatory, and quality expertise in both small molecule and biologic drug substance manufacturing and sterile injectable drug product production.

Glenn has served on the PDA Board of Directors, Science Advisory Board, and Program Advisory Board. In addition, he has chaired numerous PDA meetings, including the PDA/FDA Joint Regulatory Conference and the PDA Annual Meeting. Glenn was the founding President of the PDA Southern California Chapter and has chaired many industry task force groups, including the PDA Aging Facilities Task Force and PQRI’s Post Approval Changes for Aseptic Processing Working Group.  He is a frequent speaker at PDA events and is an active member of the PDA Manufacturing Science and Operations Program Steering Committee.  Glenn received his BS and MS degrees in Microbiology from Southern Illinois University.

Melissa Seymour, MBA
Melissa Seymour, MBA
Secretary

Melissa Seymour is the Vice President of Global QC Operations for Biogen, Inc., responsible for the comprehensive strategy and implementation for Global QC testing of raw materials, drug substance, drug product, and finished goods worldwide. Prior to this, Melissa served as the Vice President of Corporate Quality, responsible for global compliance and quality systems. 

Melissa holds BS degrees in both Biological Sciences and Biochemistry from North Carolina State University and an executive MBA from Duke University, and she is a recent graduate of the WIB Boardroom Ready program. She has more than 25 years of experience in the quality arena, including positions at Novo Nordisk Pharmaceuticals and GlaxoSmithKline.

Melissa has been highly active in PDA’s Southeast Chapter for a decade, holding leadership positions on the Board. She is involved in multiple activities with PDA, serving on the Program Planning Committees for many PDA conferences, including serving as co-chair for the 2018 and 2019 PDA Annual Meetings. She is active on the PDA PAC iAM Task Force, co-chairs the Tech Transfer IG, and has authored and reviewed multiple PDA reports and articles.

Melissa is an ASQ Certified Quality Engineer, Quality Auditor, and Quality Manager, and served on the Board of Directors for Rx-360.

 

Director Candidates

Barbara Allen, PhD
Barbara Allen, PhD

Barbara Allen is Sr. Director Global Quality External engagement for Eli Lilly and Company. For 14 years, she led the development and evolution of integrated quality standards and practices and IT systems for Lilly Quality Systems across research, development, manufacturing, distribution, and sales and marketing.

Barbara has more than 20 years of experience in the pharmaceutical industry, including quality management, technical services, validation, new product introduction, and quality assurance, both in Ireland and in the U.S. She sponsored the development of Lilly Quality Academy program for Quality professionals. Barbara is a member of the ICH Informal Quality Discussion Group, and represented industry on the expert working group for ICH Q10.

Barbara received a Bachelor Science degree in Chemistry from University College Cork, and a Doctorate in Chemistry from University College Dublin, Ireland, with a portion undertaken at the Universite de Paris, France.

Barbara is an active member of PDA and currently serves on the Board of Directors. She has participated on conference planning committees, and presented at multiple PDA events on quality, supplier quality, knowledge management, and process capability. Barbara co-leads a team working on data integrity in quality management systems. In 2013, she received a PDA Distinguished Service Award.

Jeff Broadfoot
Jeff Broadfoot

Jeff is currently the Site Head of Quality for Emergent BioSolution’s Winnipeg, Canada site where they develop and manufacture sterile biologics, primarily protein therapeutics. He has oversight responsibilities for all GXP aspects of site activities, and is directly responsible for the Quality Assurance, Quality Control, and Compliance functions.

Jeff has been active within PDA for more than 15 years and has been a member of its Regulatory Affairs and Quality Advisory Board (RAQAB) for the last 10 years. He recently completed a 3-year term as Chair of the Advisory Board and is currently serving his 2-year term as immediate Past Chair. As a member of RAQAB, Jeff has participated on numerous regulatory commenting task forces, and has supported many others, including the Quality Culture/Quality Metrics Task Force, the PAC iAM Task Force, and the Data Integrity in Manufacturing Systems Tech Report team, among others.

He studied Bioengineering and Chemical Technology and is currently working to complete an MBA.

Tia Bush
Tia Bush

Tia Bush is the Senior Vice President of Quality at Amgen. Prior to this, in her recent role as Vice President, Site Operations, she was responsible for all operations at Amgen’s 75-acre West Greenwich, RI, campus where staff contribute to the manufacture of Enbrel and other clinical trial materials. She was also responsible for leading site operations for Amgen Woburn where she oversaw the manufacturing of IMLYGIC™, a genetically modified oncolytic viral therapy. She started her career at Amgen in 1992 after obtaining her Biological Sciences and Chemistry degree from the University of Southern California. She was the recipient of Amgen’s Excellence in Quality Award, Providence Business News “Women in Business – Industry Leader” Award, 2012 Healthcare Business Association Rising Star Award, 2017 Outstanding Mentor Award and 2018 Manufacturing Strategic Leadership Award, and the 2018 Ronald McDonald Women’s Leadership award. In 2017, Rhode Island’s State Governor Gina Raimondo and Million Women Mentors Rhode Island presented Tia with a Stand Up for Stem award.

Ghada Haddad
Ghada Haddad

Ghada Haddad is currently an Executive Director at Merck & Co., leading the Global cGMP & Compliance Auditing Organization. She holds a chemistry degree, an MBA, and is a 2019 PhD candidate at TU Dublin. She has more than 20 years of experience working in the biotech, pharmaceutical, and vaccine industries at global companies. At Merck, she covers the areas of Qualification and Validation, QRM, Quality Systems, and Regulatory, including research, process development, auditing, regulatory agency inspection, and change control.

Ghada currently serves on the PDA Board of Directors and the PDA Science Advisory Board. An active volunteer, she has taken a lead role on multiple task forces, including the Paradigm Change in Manufacturing (PCMO) initiative for TR 54-2, and other Technical Report and Points to Consider teams.

Ghada is also an instructor for PDA Education, a frequent speaker at PDA conferences, and has been a member of the PDA Annual Meeting Program Planning Committee for the past five years, of which she served as co-chair for two years. Ghada has authored several scientific publications, two of which appeared in the PDA Journal. She is a mother of two young ladies, one of whom is will be graduating Pharmacy School in 2020.

Ivy Louis
Ivy Louis

Ivy Louis, a pharmacist with a focus on behavioral and value analysis of people, an MBA in Human Resources, and a total of 30 years of experience, finds ways to challenge the limits of learning, education, and implementation.

As the Founder-Director of Vienni Training & Consulting LLP, Ivy believes that people and their understanding of the-what, the-why, and the-how play ‘the’ crucial role in all bio and pharmaceutical operations.

Ivy has worked in the manufacturing and quality domains at CIPLA and the manufacturing line up of Astra-IDL. Her work in filtration technology operations, and experience heading the Access ServicesSM at Millipore India, have built her expertise in aseptic practices and filter validation services.

She is a forerunner in creating benchmarks in the propagation and education of aseptic filtration and validation and services for pharmaceutical customers in research, production, and quality control/assurance areas in India and Asia.

Currently, she helps companies achieve measurable improvements to operational and assurance efficiencies through practical and implementable learning and consulting services.

She has been a member of PDA for 15 years and was actively involved in the creation of the PDA India Chapter in 2013. She has been a Chapter Officer and is currently responsible for the activities of the Chapter as its President.

Steven Lynn
Steven Lynn

Steve is currently the principal consultant/owner for Lynn Consulting, LLC, advising and working with life science sector company executives on pre- and post-market GxP issues. Prior to this, Steve was the Global Head of Group (Corporate) Compliance and Audit at Novartis AG, leading GxP compliance and audit functions for all Novartis pre- and post-market units. Before that, Steve was the inaugural Vice President of Global Quality Compliance at Mylan, Inc.

Steve also spent nine years working in multiple units at the U.S. Food and Drug Administration, in roles of increasing importance/responsibility in the Center for Drug Evaluation and Research (CDER), Center for Device Evaluation and Radiological Health (CDRH), and the Office of Regulatory Affairs. In his last role with FDA, Steve served as the Office Director of CDER’s Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance, where, he was responsible for CGMP oversight of all drugs manufactured and/or imported into the U.S.

Steve received a BS in Biology from Bethany College in Bethany, WV, and an MS in Quality Systems Management from the National Graduate School in Falmouth, MA. He is a Senior Member of the American Society for Quality (ASQ) and is an Excellence in Government Program Senior Fellow.