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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Building a Foundation and Culture for Quality Risk Management Integration Workshop

December 11, 2019, Washington, DC

  • Susan Schniepp

    Susan J. Schniepp

    Regulatory Compliance Associates Inc.

    Susan Schniepp has 35 years experience in Quality Assurance. She is a Distinguished Fellow with Regulatory Compliance Associates Inc. advising clients on overall Quality and Compliance strategies. She was previously Vice President of Quality and Regulatory Affairs for Allergy Laboratories, Inc. and OsoBio Pharmaceuticals, LLC where she oversaw the activities of the Quality Assurance, Quality Control and Regulatory Affairs operations for the companies.  She has had responsibilities for laboratory analysis, method validation, complaints, labeling, investigations, compendial affairs, and other quality systems during her 35 years in the industry.  As an active member of PDA, Sue served on the Board of Directors from 2011-2014 and has been a member of the PDA/FDA Joint Regulatory Conference since 2001, chairing the conference in 2007 and co-chairing it from 2010 through 2014.  In addition to her involvement with PDA/FDA Joint Regulatory Affairs Conference, Sue is Chair of PDA’s Regulatory Affairs/Quality Advisory Board and has presented at many PDA venues.  In 2007 she was the recipient of PDA’s Distinguished Author Award for the book Understanding the United States Pharmacopeia and the National Formulary:  Demystifying the Standards-Setting Process, in 2008 she received PDA’s Distinguished Service Award and in 2009 she was presented the PDA Gordon R. Personeus Award.  Since 2007, Sue has served as a member of the editorial advisory board for Pharmaceutical Technology Magazine as well as authoring a quarterly column called “Insider Solutions”.  Sue was Chair of a USP Monograph Development Expert Committee from 2005-2010.

  • Magaly Aham

    Magaly E. Aham

    Takeda

    Magaly E. Aham, MSc currently works at Takeda Pharmaceuticals as the Head of Knowledge Management under Global Quality Compliance and Systems. Prior to joining Takeda she worked in consulting for Pharma-BioServ Inc., MedImmune, Pfizer, Wyeth and Schering Plough in positions of increased managerial responsibility. She holds a bachelor’s degree in Chemistry from the University of Puerto Rico and a Master Degree in Bioscience and Regulatory Affairs from the Johns Hopkins University in Maryland, US. She has comprehensive management experience in Quality Assurance, Quality Systems, Compliance, Quality Control, Validation and Manufacturing Operations. Magaly has participated as a lead in companies undergoing remediation efforts such as Consent Decrees and Warning letter environments in which she has developed expertise in quality systems design and implementation and Risk Management. She is Kepner-Tregoe Problem Solving Decision Making(PSDM) Certified Trainer, former ASQ Quality Auditor (CQA), US-RAC, and a PR Licensed Chemist. On the QRM Interest Group Community she is the Co-Lead for the QRM IG. She has also been participating as planning committee member for the PDA Annual Meeting for the past couple of years.

  • Denyse Baker

    Denyse D. Baker, PE, RAC

    AstraZeneca

    Denyse Baker, P.E., RAC, is Senior Director of Regulatory Affairs Policy with AstraZeneca supporting policy development and advocacy efforts related to biologics and biosimilars, respiratory drug development and PDUFA VII. She has 30 years of pharmaceutical industry and FDA experience including quality systems, CMC regulatory, parenteral manufacturing and engineering. Denyse is an active volunteer with PDA’s Pharmaceutical Quality and Culture metrics programs and has trained over 100 regulators on the Quality Culture Assessment Tool. She is a contributing author to several publications on Data Integrity and Quality Culture. Denyse is a licensed professional engineer and holds RAC certifications in US and EU regulatory affairs.

  • Marcello Colao

    Marcello Colao, MS

    GSK Vaccines

    Marcello Colao currently holds the position of Director Regulatory & Technical Lifecycle within the Global Quality organization of GSK Vaccines aimed at sustaining and leveraging the successful lifecycle management of GSK vaccines from both a regulatory and technical perspective.

    Marcello joined GSK Vaccines in 2012 as Director Quality & Regulatory Compliance to lead the Regulatory Conformance Transformation of the company. Prior to that, he worked for Pfizer where he held positions of increasing responsibilities within the Global Quality Operations organization.

    Marcello holds a Master Science degree in Chemistry and has 20+ years experience in the pharmaceutical industry with an extensive knowledge of pharmaceutical operations, Quality Systems as well as Regulatory Compliance matters.

  • Andrew Hopkins

    Andrew D. Hopkins

    AbbVie, Inc.

    Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His has worked in the industry over 35 years. Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies. Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This role included:

    • Inspections across the world, including inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of areas including, sterile products, biological products, blood components and plasma.
    • Chairperson of the Inspectorates CMT (working with marginally compliant companies)
    • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites)
    • Inspector training and mentoring
    • Involved in writing of regulatory guidance documents including:
      • MHRAs Data Integrity guidance
      • EMA guidance on water systems
      • Chair for the working group for the revision of Annex 1
    • Supporting external industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20.

    Prior to joining the MHRA Andrew worked for more than 20 years in various areas and technologies in the Pharmaceutical industry.

  • AnetteYan Marcussen

    Anette Yan Marcussen, MPharm

    NNE A/S

    Anette Yan Marcussen is an experienced Consultant with a demonstrated history of working in the pharmaceutical industry. Profound and proven leadership and management skills from multiple jobs in international companies like Novo Nordisk and Genmab. Expertise areas are Aseptic Pharmaceutical Production, Quality and Regulations, Quality Intelligence and emerging new regulations.

    Anette's engagement in PDA include Vice Chair in Regulatory and Quality Advisory Board, member in planning committees for conferences, Co- Chair in Pharmacopoeia Interest Group, and member in some task forces.

  • Tina Morris

    Tina S. Morris, PhD

    PDA

    Dr. Morris is Vice President, Scientific and Regulatory Affairs at the Parenteral Drug Association (PDA). Dr. Morris oversees PDA’s scientific and regulatory affairs activities, which include industry-leading technical reports and other scientific outputs, the newly launched standards-development program through the American National Standards Institute (ANSI), regulatory commenting, and overseeing PDA’s three technical/regulatory advisory boards. Previously, Dr. Morris held several leadership positions at the United States Pharmacopeia (USP), including as the Global Head of Biologics and Senior Vice President of Compendial Science. Before joining USP in 2003, Dr. Morris worked in the biopharmaceutical industry, with an expertise focus on analytical development and product characterization for recombinant biotherapeutics. Before joining industry, she completed postdoctoral research in infectious diseases at the National Institutes of Health in Bethesda. She holds a Ph.D. in molecular virology from the Medical University of Luebeck, Germany, and a Masters Degree in Biology from the Carl von Ossietzky University of Oldenburg, Germany.

  • Lori Richter

    Lori Richter

    ValSource, LLC

    Lori Richter is a Senior Consultant at ValSource. She holds a Bachelor of Science in Microbiology and over 20 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management (QRM), Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to becoming a consultant, she held previous roles such as a Site Risk Manager at a biologics facility, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of the global team responsible for the development and deployment of the QRM program across the Roche/Genentech Pharmaceutical Division. She has developed many QRM training modules and delivered training to both Health Authorities and industry teams. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems”. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program and teaches courses regularly at the training facility in Bethesda, Maryland. Lori is pursuing her PhD at Technological University Dublin.

  • Janeen Wilkinson Skutnik

    Janeen Skutnik-Wilkinson

    Biogen

    Ms. Skutnik is the Associate Director for Quality Intelligence at  Biogen, the the current Chair of IPEC Americas.  Her former positions include: Vice President at NSF DBA,.Director /Team Leader of Quality & Regulatory Policy at Pfizer, responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues. She has over 24 years experience and expertise 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 is a member of the ICH IWG for ICH Q3D Elemental Impurities, and was also 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 Regulatory Acceptance of Pharmacopoeial Interchangeability. She is the IPEC Delegate to the ICH Assembly and ICH Informal Quality Discussion Group.

  • Jason Urban

    Jason M. Urban, PhD, CA-AM

    Bristol-Myers Squibb

    Jason Urban, Ph.D. CA-AM leads Bristol-Myers Squibb’s External Engagement Global Quality function in Global Pharmaceutical Development & Operations. Jason is accountable for the development and execution of the GxP External Engagement strategy, this includes: Ensuring that BMS is recognized as a thought leader in the areas of scientific innovation and quality; And promoting an organizational risk-based mind-set through early actions on issues of potential impact to operations, quality, or compliance. Additionally, Jason is also the Global Process Owner for GPS’s Quality Risk Management.

    Prior to his current role, Jason led Celgene’s Business Strategy & Process Excellence function with responsibilities for business development/due diligence, long-range planning, operational excellence, and communications. While at Celgene, he also led Quality’s Global Quality Risk Management and Surveillance department, responsible for quality metrics, health authority communications and risk management. Prior to Celgene, Jason held risk management roles at the U.S. Food and Drug Administration. During that time, he led activities in the areas of quality, supply chain, imports, regulatory, and policy development.

    Jason holds a Ph.D. in Cellular Biology, with postdoctoral residencies in molecular neuroscience and cell/gene therapy. Jason is a member of the editorial board of Life Science Leader and a certified Alliance Manager.

  • Jaap Venema

    Jaap Venema, PhD

    United States Pharmacopoeia

    Jaap Venema, Ph.D., is Executive Vice President and Chief Science Officer (CSO) for USP. He leads the organization’s scientific strategy and is responsible for the development of quality standards for medicines, dietary supplements, food ingredients and healthcare, including collaborations with other pharmacopeia and scientific groups.

    Dr. Venema guides USP’s exploration of emerging technologies that may inform future quality standards and oversees USP’s Up-to-Date program, which continuously evaluates and revises standards to reflect current and best practice. Dr. Venema also serves as Chair of the Council of Experts, spearheading USP’s work developing science-based standards. This body guides and approves the draft standards developed by USP’s numerous expert committees, comprised of nearly a thousand scientific experts from academia, industry, healthcare, as well as government agencies.

    A native of the Netherlands, Dr. Venema earned his Master’s degree in Chemistry from the Free University of Amsterdam, and his Ph.D. in Biochemistry and Molecular Biology from Leiden University in the Netherlands.

  • Anne Greene

    Anne Greene, PhD

    TU Dublin, School of Chemical and Pharmaceutical Sciences

    Anne Greene leads the Pharmaceutical Regulatory Science Team (PRST) in TU Dublin, where she is also a senior lecturer and director of the several MSc. and BSc. Pharmaceutical Programmes, including the TU Dublin MSc in Pharmaceutical Validation Technology.  She has supervised several students to PhD awards in areas of Quality Risk Management, Knowledge Management, Operational Excellence and PAT.

    Prior to embarking on an academic career, Anne worked at a senior level for several years in the pharmaceutical sector in Validation and Technical Management roles. Anne has a PhD in Synthetic Organic Chemistry from University College Dublin, and is currently a member of committee of the Irish Chapter of PDA. Anne is also on the Board of Directors of Regulatory Science Ireland (RSI) and is chair of the Corporate Development Committee. 

  • Guy Villax

    Guy Villax

    Hovione

    Guy Villax has been the Chief Executive Officer of Hovione since 1997.

    Prior to that, he held positions with Price Waterhouse in London and Hovione in the Far East.

    He has a degree in Accounting and Financial Management from the University College at Buckingham.

    He was a member of the board of CEFIC’s European Fine Chemicals Group from 2004 to 2016, he was a member of the board of Rx-360 from 2009 and chair in 2015/6.

    Guy was part of the EFCG team that worked with the European Parliament to petition the EU Commission for safer APIs, an effort that ultimately resulted in the Falsified Medicines Directive. In 2007 Guy testified on behalf of EFCG before a US Congress sub-committee hearing that looked into FDA’s foreign inspections. In 2011 he was on the Industry team that negotiated GDUFA.

    He is currently a trustee of the Universidade Nova de Lisboa.