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ISPE Announces New ISPE Affiliate and Chapter Chairs and Co-Chairs

ISPE
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ISPE has announced the new 2024-2025 ISPE Affiliate and Chapter Council Chairs and Co-Chairs. ISPE Regional Affiliate Councils collaborate efficiently with the international ISPE organization and local regional peers to ensure optimal alignment and support for local success. ISPE currently has three regional affiliate councils including: Asia-Pacific Affiliate Council (APAC), European Affiliate Council (EAC), and North America South America Affiliate Council (NASAAC). They recommend policies and procedures to CEO/President and International Board of Directors that will enhance services for Members in the region.

Affiliate/Chapter leaders serving as Chair or Co-Chair represent their region’s ISPE Affiliates/Chapters for a two-year term. In the second year, the Co-Chair transitions into the role of Chair. These individuals have typically previously served on an Affiliate/Chapter board in a leadership position, attend all regional council meetings, are encouraged to attend the ISPE Annual Meeting & Expo, collaborate with their Regional Council Co-Chair, and must be accessible to regional Affiliate/Chapter leaders.

The Affiliate/Chapter Regional Council leaders oversee and coordinate the quarterly regional meetings, with support from ISPE staff. They collaborate with their councils to establish regional goals and foster strong relationships among all Affiliates/ Chapters within their region.

Fun Fact: Affiliates/Chapters are one in the same. They are called ISPE Chapters if they reside within the United States and ISPE Affiliates outside the United States.

The following pharmaceutical professionals have been selected to these positions.

2024-2025 ISPE Asia-Pacific Affiliate Council (APAC) Chair and Co-Chair Leads

Vendor Quality Lead DP Japan, Global Quality, GMP GSP Quality Operations
UCB SA
ISPE APAC Chair

ISPE APAC Chair: Hiroshi Yamaguchi, Vendor Quality Lead, DP Japan, Global Quality, GMP GSP Quality Operations, UCB SA, has assumed the role of ISPE APAC Chair. Yamaguchi also serves as Past Chairman of ISPE Japan Affiliate (May 2022 – Present) and Board of Directors for the ISPE Japan Affiliate (May 2013 – Present). He previously served as Chairman of ISPE Japan Affiliate (May 2021 – May 2022).

Yamaguchi is based in Japan and has previously resided in Singapore as well as Switzerland. His current jobs include: UCB, S.A./UCB Japan, Global Quality, CMO Management; University Lecturer, GMP Management; and Technical Advisor for a chemical and food company.

ISPE APAC Co-Chair: Sasivimol Kittivoravitkul, PhD, Managing Director, Advance Pharmaceutical Manufacturing Co., Ltd., has been selected as the ISPE APAC Co-Chair. She resides in Thailand and has more than fifteen years of experience in the pharmaceutical industry. Kittivoravitkul has previously served as a volunteer ISPE committee member for the ISPE Thailand Affiliate for eight years, in the roles of ISPE Thailand Affiliate Secretary and Treasurer. She has worked in pharmaceutical manufacturing since 2007.

Kittivoravitkul was responsible for constructing a new non-sterile plant (APm) in Ayutthaya as a project leader. She was involved in the design of the new plant, commissioning, qualification and validation activities. Besides being the managing director of the company, she is also the Quality Management Representative (QMR).


2024-2025 ISPE European Affiliate Council (EAC) Leads

ISPE EAC Chair: Ricardo Jorge Milheiro Dias Tavares Grilo, Associate Director at Hikma Pharmaceuticals, has assumed the role of ISPE EAC Chair. He is currently a member of the ISPE European Leadership Team and is part of the ISPE Iberia Affiliate board of directors.

Grilo is a senior executive with twenty-four years of experience in the pharmaceutical industry. He is a Chemical Engineer and holds an MBA. He is skilled in active pharmaceutical ingredients (API) production processes, quality management systems, Lean Six Sigma, and was exposed to regular US Food and Drug Administration (US FDA) audits. Grilo has spent the last fourteen years working in Laboratórios Atral, as Quality Assurance manager, then Director of Quality Unit running the Quality Control and Quality Assurance Department. At Laboratórios Atral, he was also responsible for external qualifying audits (e.g., Europe, China, South America) and project management, leading the construction of two plants. For the last six years of his tenure at Laboratórios Atral, he was the Site Director. In September 2024, he joined Hikma Pharmaceuticals as Associate Director of Engineering.

Associate Director - Pharmaceuticals & Life Sciences
Mace

ISPE EAC Co-Chair: Zam Thahir has assumed the role of Co-Chair of the ISPE EAC.

Thahir is currently the Associate Director for Pharmaceuticals and Life Sciences at Mace Consult and is the technical lead on Mace’s pharma projects. He is also the current Chair of ISPE United Kingdom Affiliate and serves on a variety of ISPE Communities of Practice (CoPs), including the Critical Utilities CoP, Pharma 4.0™ CoP, Sustainability CoP and more.

Thahir is a Chartered Process Chemical Engineer with the Institute of Chemical Engineers and holds a Master in Engineering degree in Chemical Engineering from the University of Cambridge. He is the lead engineer on critical utilities for capital projects.

Thahir has extensive experience in process engineering and process validation in both pharma operations and design, in both secondary and primary manufacturing and in various dosage forms and modalities including steriles, oral solid dosages (OSDs), powders, and medical devices. Key skills include process optimization, critical and clean utilities, technology transfer (NPI), statistical process control, deviation investigations, process validation, and equipment qualification. Previous employers include IPS, Thermo Fisher Scientific, Boston Scientific, and Cambrex Corporation.


ISPE 2024-2025 North America/South America Affiliate Council (NASAAC)

ISPE NASAAC Chair: Shannon Goodson, Senior Project Manager, Barry-Wehmiller Design Group, Inc., has taken on the role of ISPE NASAAC Chair. Goodson has been a member of ISPE since 2006. She has held several offices at the local ISPE Chapter level, including as current ISPE Midwest Chapter President and past ISPE South Central Chapter President, and has presented at several conferences.

Goodson has over twenty-seven years of process and project engineering experience, with over twenty-five years in the pharmaceutical industry. Her emphasis is on life science projects, with extensive experience in aseptic filling, biotechnology, oral solid dosages, liquid dosages, primary/secondary packaging, and more. She has demonstrated success in delivering on-time projects with good results, is manufacturing- and customer-oriented, and has experience with validation projects. She was also an Instructor of Process Validation of Medical Devices for Center for Professional Innovation and Education, Inc., for two years.

ISPE NASAAC Co-Chair: Daniel D'Aquila, Senior Director, Manufacturing Operations, GSK, has been selected to serve as the ISPE NASAAC Co-Chair. He has been a member of ISPE for twenty-eight years and has been a board member of the ISPE Delaware Valley Chapter (DVC) for the last seven years. After several years of leading DVCs Education Committee, he most recently held the role as chapter President for the 2023-24 program year. D’Aquila had presented numerous national and local ISPE events on the topics of pharmaceutical facility design, and environmental sustainability.

D’Aquila has been at GSK for 15 years. Over his time at GSK, he has held several leadership roles in the areas of engineering, validation, environmental sustainability, process safety, regulatory compliance and innovative manufacturing technology development. Prior to joining GSK, he worked for more than twenty years in the architectural and engineering business, serving pharmaceutical clients internationally. His expertise is in the design and delivery of GMP pharmaceutical manufacturing facilities.

Learn More About ISPE Affiliate and Chapters