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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Optimizing Quality Risk Management Conference

December 12-13, 2019, Washington, DC

  • Denyse Baker

    Denyse D. Baker, PE, RAC


    As a member of the Policy, Intelligence and Regional Strategy team at AstraZeneca, Denyse is focused on policy developments related to FDA, biologics/biosimilars, COV19, post approval change management, quality culture, metrics, and e-labelling. She also has more than 30 years pharmaceutical industry experience with PDA, US FDA, and Eli Lilly in leadership roles across multiple functions including regulatory affairs, quality systems, parenteral manufacturing, and engineering.

    Denyse is a member of PDA’s Regulatory and Quality Advisory Board, co-leader of the Quality Maturity Task Force and trainer for quality culture assessments. Denyse earned a B.S in Mechanical Engineering from Northwestern University, is a licensed professional engineer, and holds RAC certifications in US and EU reg. 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.

  • 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.

  • 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


    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.

  • Tais Conti

    Tais H. Conti, MA

    Bristol-Myers Squibb

    With more than 20 years of experience with pharmaceuticals, biotech and other life science products, Tais has worked in the areas of Manufacturing Operations, Compliance, Quality Assurance, Quality Systems, including Investigations, Change Control, Validation & Qualification, Regulatory Inspections, Laboratory Operations, Maintenance & Engineering, Supply Chain and Logistics. With increased responsibilities along the years, she has been leading teams and organizations towards Quality Systems implementation and/or enhancements such as QRM programs, as well as Operational Excellence and Lean QA.

    Tais is currently the Quality & Compliance Senior Manager of Bristol-Myers Squibb Brazil site. Prior to that, she had worked for Schering-Plough and Baxter Healthcare. She holds a Bachelor degree in Pharmacy-Biochemistry by the University of Sao Paulo and a Master Degree in Industrial Administration.

    She led the implementation of the QRM Program for BMS Brazil site and, most recently, she was in charge of revamping the QRM program of one of the majors BMS manufacturing biotech site, by instituting an agile, robust and sustainable program. She is also a member of the BMS Global QRM Project Organization.

  • Heather Crews

    Heather A. Crews, BS

    Merck & Co., Inc.

    Heather Crews is an Associate Director in the Quality Management Systems group at Merck, where she has supported global standardization of Quality Risk Management for the last three years. Heather has been with Merck for 9 years and has experience in both technology and quality. Prior to joining Merck, Heather was a Process Engineering with CRB, Consulting Engineers. She holds a Bachelor of Science in Chemical Engineering with a concentration in Biotechnology from North Carolina State University.

  • Monica Hueg

    Monica Hueg, MSSc


    Monica Hueg has more than 18 years of experience with biotech, pharmaceuticals and the construction and production of life science facilities.

    Monica’s focus is on facilitating strategic business decisions with special attention to quality, compliance and lean qualification such as implementing ASTM E2500. She consults on strategic planning for future production and quality improvements, often in connection with compliance gap analysis and assessments.

    Monica has a master's degree in social science from Roskilde University, Denmark, and extensive theoretical insight and practical experience within GMP and compliance. She is involved in the analysis, planning, implementation and completion of a wide range of projects within the pharma industry globally.

    Monica regularly teaches courses within GMP and compliance and she has developed a number of courses within the topic.

  • Anil Sawant

    Anil Sawant, MSc, PhD

    Merck & Co., Inc. / MSD

    Dr. Sawant has over 25 years of experience in Quality Operations, GXP Compliance Operations, Auditing, and Ethics & Research Integrity functions.

    He has extensive experience working on small molecules, biologics, and vaccines, various dosage forms from injectable to topical, and medical devices and combination products.

    Prior to joining Merck, Dr. Sawant was Vice President, Enterprise Regulatory Compliance, Johnson & Johnson.  Prior to J&J, he served as the Vice President, Compliance & Research Integrity for Wyeth Pharmaceuticals (now Pfizer).

    Dr. Sawant holds a B.Sc. Honors and a M.Sc. Honors in Microbiology from Panjab University, India and a Ph.D. in Microbial and Biochemical Sciences from Georgia State University, Atlanta, GA. He has published numerous papers in peer reviewed microbiology and medical journals on glycoproteins, fermentation, medical device development, and GLP and GCP studies.

    Dr. Sawant has been the lead for four PDA Technical Report and Co-Chairs the PDA Task Force on Data Integrity.

    Dr. Sawant currently serves on the/PDA Board of Directors, Board of Directors Mind Your Brain Foundation and has served on Board of Directors of Georgia State University Alumni Association. He is recipient of the Georgia State University Distinguished Alumni Achievement Award and the PDA Distinguished Service Award.

  • Michael Schousboe

    Michael Schousboe, Msc Pharm

    Novo Nordisk A/S

    Michael Schousboe is Principal Specialist, Quality Risk Management in the Corporate Quality function of Novo Nordisk. He has the overall responsibility for maintaining a well performing and compliant process of Quality Risk Management across the quality management system of Novo Nordisk. Prior to this Michael has successfully managed a wide range of projects providing benefits across Novo Nordisk.

    Michael holds a master’s degree in pharmaceutical science (M.Sc. Pharm.) from the Royal Danish School of Pharmacy, he is a Design For Six Sigma Black Belt and has many years of experience within the pharmaceutical industry. With a QC laboratory background and later as a QA professional Michael has worked with qualification and validation within the areas of computerized systems, laboratories, as well as production of drug products and API in different Danish pharmaceutical companies. He is experienced as a speaker on the aspects of validation and Quality by Design, Quality Risk Management and Quality Systems, and has chaired several conferences. Furthermore, Michael is an experienced auditor and has served as a qualified person.

  • Sofia v Berlekom

    Sofia van Berlekom, MSc


    Sofia van Berlekom, Global Quality Director, is the Global Business Process Owner (BPO) for Quality Risk Management at AstraZeneca Operations since November 2016. As the BPO she leads the global QRM network and is both responsible for QRM process improvements, compliance and system support as well as quality risk roll up within AstraZeneca Operations.

    Prior to the BPO role she has been with AstraZeneca Sweden Operations since 1998 where she has held various quality leadership roles supporting API, oral solid dose, packaging and inhalation device manufacturing as well as leadership roles supporting the QMS processes; complaints, change control, internal and external audits, computerized systems and new products introductions.

    Sofia van Berlekom received her MSc in Chemical Engineering (1993) and Licentiate in Organic Chemistry (1998) at Chalmers University of Technology, Gothenburg, Sweden.

  • Kelly Waldron

    Kelly Waldron, PhD

    Valsource LLC

    Dr. Kelly Waldron is currently a senior consultant with ValSource and a member of the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (formerly Dublin Institute of Technology) in Dublin, Ireland. She has particular expertise and a specialized focus on the development and implementation of innovative approaches to quality risk management (QRM) and has authored numerous industry and academic papers on the topic. Dr. Waldron’s expertise extends to various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality system design, quality strategy and planning, deviations/investigations, CAPA, change management, data integrity, audit and inspection programs and response, and design control. She holds a BA in biology from Boston University, an MBA in pharmaceutical management from Fairleigh Dickinson University, and a Ph.D. in pharmaceutical regulatory science (thesis in QRM) from the Dublin Institute of Technology. She currently resides in New Jersey, USA and can be reached at [email protected]