ISPE International Board of Directors
Chair: Alan Mac Neice
Mr. Mac Neice is Senior Director for Projects for Elan's Biologics division in
Ireland. During his career, Mac Neice has had responsibility for both capital projects and operations,
including maintenance, facilities, safety and environment responsibilities. Mac Neice holds a degree in
chemical engineering and a number of business qualifications including an MBA. His 24-year career has been
entirely within the manufacturing sector of the pharmaceutical industry. He has worked with five different US
and European multinationals in a diverse range of manufacturing operations, including chemical APIs, biotech
APIs, aseptic dose forms, oral solid dose forms, and the extraction of natural medicine. A member of the
Ireland Affiliate since 1992, Mac Neice has been a committed ISPE volunteer as an organizer, speaker, and
advisor. From 1998 to 2004, Mac Neice served on the Irish Affiliate Management Committee, including a
two-year term as Chairman. Under his stewardship, the Affiliate membership grew by 60% and the first Student
Chapter outside of North America was established. Mac Neice has been a Member of the Board since 2005.
Vice Chair: Andre Walker, CPIP, BiogenIdec Manufacturing ApS
Mr. Walker is Director of Manufacturing Engineering and Facilities for Biogen
Idec's Large Scale Commercial Manufacturing Operation in Hillerod, Denmark, were he is responsible for the
maintenance and engineering support of all equipment and utilities, including the metrology and validation
functions. He and his family recently relocated to Denmark from the USA, where he held a similar role at
Biogen Idec's Manufacturing Operations in Cambridge, Massachusetts. He has more than 29 years of experience
in the areas of process development, scale-up, implementation, validation, and manufacturing support. His
past contributions to the Society include four years on the North American Affiliate Council, two of which he
served as Chair, and several years on the Boston Area Chapter Board, including terms as Vice President,
Program Chair, and President.
Treasurer: Dr. Arthur (Randy) Perez, PhD, Novartis Pharmaceuticals Corporation
Dr. Perez currently holds the position of Executive Expert, IT Quality Assurance for
Novartis Pharmaceuticals. His responsibilities at Novartis include a wide range of IT Compliance issues, such
as GxP, Sarbanes-Oxley, and data privacy. He serves on several global Novartis teams dealing with computer
systems compliance issues, and has authored many of the firm's global GxP compliance policies. During his
26-year tenure at Novartis, he has developed a broad range of experience, working as a chemistry group leader
in process research, managing a chemical manufacturing process validation program, and running a QA
validation group for pharmaceutical operations.
Dr. Perez was a member of the PhRMA Computer Systems Validation Committee from 1995-1999, and was instrumental in the formation of GAMP Americas when that group started in 2000. From 2002-2008 he was Chairman of GAMP Americas and has been a member of the global GAMP Council since 2002. He initiated and led the Global Information Systems SIG, who wrote a GAMP® Good Practice Guide that was published in 2005, and was part of the core team that led the development of GAMP® 5, published in 2008. Dr. Perez has been a speaker and a course leader at numerous conferences in the US and Europe, and has been published in industry journals and textbooks. In 2005 he was elected to the ISPE International Board of Directors.
Secretary: Dr. Charlotte Enghave Fruergaard, PhD, NNE Pharmaplan
Dr. Enghave Fruergaard is employed as Senior Consultant in the Finished Product
Department at NNE Pharmaplan in Denmark. Previously she was manager of Sales & Marketing and before that
responsible for conceptual designs of new pharmaceutical facilities. She has 15 years of experience with
pharmaceutical projects, a broad experience within pharmaceutical manufacturing of Sterile Bulk and is a
leading expert within isolator and barrier technology and associated sterilization techniques.
Dr. Enghave Fruergaard holds a M.Sc. in mechanical engineering and a Ph.D. in measuring technique. She has international experience from an EU founded project where she was stationed at Physicalische Technische Bundesanstalt in Germany. During this project, Dr. Enghave Fruergaard also gained the PhD degree within metrology.
Dr. Enghave Fruergaard has been a member of ISPE for 15 years. She is co-founder of the ISPE Nordic Affiliate in 2000, and was Chairman of the Nordic Affiliate for the period 2006-2007. She is an active member of several ISPE committees. Furthermore she has been the Co-Chairman of the yearly reoccurring ISPE "Barrier Isolation Technology Conference" since 1999.
Director: Damian Greene, Pfizer Inc
Mr. Greene is Senior Director Plant Network Strategy, API for Pfizer Global
Manufacturing in New York. He has a BE in chemical engineering from the University College Dublin, and an MSc
in chemical engineering from the University of Missouri at Rolla. Mr. Greene began his career with Pfizer as
a Production Supervisor at the Terre Haute Indiana site. He has more than 25 years experience in
pharmaceutical and fine chemical manufacture, and has worked for Pfizer in a number of operational, financial
and strategic roles, including at the Ringaskiddy Ireland site, at the Groton Connecticut site, and at Pfizer
New York Headquarters. He previously served as Chair of the ISPE Community of Practice Council as well as
Chair of the API Community of Practice.
Director: Winnie Cappucci, Bayer Healthcare
Ms. Cappucci is currently the Associate Director Product Supply IT Systems
Compliance, North America. She has worked in the pharmaceutical industry for 39 years and in global roles for
the last 14 years. Ms. Cappucci has worked as a business process owner, an IT professional and lastly as a
quality and compliance specialist in a highly regulated environment. In her current role Ms. Cappucci is
responsible for developing and implementing Bayer's global standards for computer systems compliance. She is
a member of the GAMP America Steering Committee, the GAMP Editorial Board, and Co-Chair of the GAMP
Outsourcing SIG. She is also a member of the PDA Industry Advisory Board for Technical Report 32 (Auditing of
Suppliers Providing Computer Products and Services for Regulated Operations) and the Audit Resource Center
repository.
Director: Doyle R. Johnson, CDI Life Sciences
Mr. Johnson has served as Sr. Director, Director and Manager in the Facilities and
Engineering Group at MassBiologics, a MAbs Cell Culture and Fill/Finish Operation in Boston, Massachusetts.
He has more than 25 years of experience designing, building and operating BioPharma and Chemical Process
Plants. Mr. Johnson served as President of the ISPE Boston Chapter this past year, and prior to that served
for five years on the Board of Directors of the Boston Chapter, including Vice President last year. Under his
leadership the Boston Chapter has implemented a Young Professionals Initiative, a GAMP program at the Product
Show and Educational Programs with MIT and Tufts University. He has lived and worked in both the US and
Europe. Mr. Johnson most recently served in a leadership role for the MassBiologics Biopharma plant from
initial design through startup/commissioning to FDA licensure, followed by implementation of a CMMS. He holds
a BS degree in Chemical Engineering from Cornell University, an MS in Organic Chemistry from Northeastern
University and an MBA from Babson College.
Director: Andrzej Szarmanski, Polpharma S.A.
Mr. Szarmanski is Quality Director at Polpharma SA, a European pharmaceutical
manufacturer involved in manufacture of non-sterile and sterile pharmaceutical products as well as active
pharmaceutical ingredients with headquarters in Poland. He has 17-years experience in pharmaceutical
industry, involved in various roles in production, engineering and quality assurance. One of his previous
positions included a role of Quality Director at GlaxoSmithKline Pharmaceuticals SA in Poland.
Mr. Szarmanski completed a MSc degree in Chemical Technology from Technical University in Gdansk in 1992 and MBA from Poznan University of Economics and Georgia State University in 2005. He has published and lectured on quality relating topics in Poland and abroad. In May 2008 he was a guest speaker at PIC/S conference presenting industry view on GDP aspects. Mr. Szarmanski currently serves as a reviewer of articles for Pharmaceutical Engineering. He has been involved in the Poland Affiliate since the very beginning in 1999, and for the last four years chaired the Poland Affiliate. Since 2008 he was Vice-Chair of the European Affiliate Council.
Director: Morten Stenkilde, Novo Nordisk A/S
Mr. Stenkilde is currently Quality Director, Insulin Filling plant, Tianjin, China,
Novo Nordisk A/S. He has more than 15 years of pharmaceutical manufacturing experience in the areas of solid
dosage, contract manufacturing and sterile manufacturing. He has been part of construction projects for both
solid dosage and sterile manufacturing. Mr. Stenkilde has international project expierence from Denmark,
Brazil and recently China. He has experience from production departments, Quality departments, logistic
departments as well as project management in the pharmaceutical industry. He has been assigned to the
construction of Novo Nordisk A/S facilities for insulin filling in China. Mr. Stenkilde is responsible for a
proactive Quality organization to ensure fast delivery and release to the world wide market. This includes
close corporations authorities in China.
Mr. Stenkilde is a member of the newly established Steering committee for ISPE Greater China. He gave a speech to the Chinese FDA's inspectors to support development of the pharmaceutical industry in China. He is hosting the COP for Sterile Manufacturing in China and is participating actively in developing and implementing strategies for ISPE Greater China.
Director: Antonio Buendia, Lilly SA
Mr. Buendia is currently Project Engineering Manager, Alcobendas (SPAIN), Eli Lilly
and Company. He has more than 15 years of pharmaceutical manufacturing experience in the areas of project
management, facilities master planning, facilities and utilities design, solid dosage, liquid dosage, R&D
labs (basic chemistry and biological), automation technology and qualification of facilities, utilities and
equipment. He has played a key role in seamlessly transforming Alcobendas plant into a reliable, competitive
and flexible plant capable to manage complexity related to product supply and new products launching. The
project portfolio included Japan manufacturing capability, new forming areas, and packaging expansion by
300%, without disturbing operations.
Mr. Buendia previously served as Chair of the ISPE Spain affiliate since Jan 08. The Affiliate was founded in late 2006 and he and the Steering Committee have consolidated and thrusted the association, doubling the members, developing an intensive events calendar recognized as "high quality" events, creating local COPs and establishing sound relations with Spanish Health authorities.
Mr. Buendia holds a Master in Engineering from the Comillas Pontifical University in Madrid, Spain.
Director: Joan Gore, RPh, Eli Lilly & Co
Ms. Gore is the Manager of the Clinical Trial Packaging and Support Services
organization at Eli Lilly and Co. Gore, a registered pharmacist, has expertise in both oral and parenteral
manufacturing, packaging, parenteral formulation development, CT material supply, GMPs, import/export
regulations, supply chain management, global business process improvement, and third party management. The
majority of her nearly 25-year career at Eli Lilly has been spent in the Clinical Trial Materials area.
During that time, she also led strategy development for CTM and the broader product development division. Ms.
Gore has been on the ISPE Clinical Materials Committee (North American Regional Steering Committee) since
2002 and has served as the Chair of the committee. During her time on the steering committee, she helped
revise the Introductory US Clinical Trial Materials Training Guide, was an author of the Comprehensive Guide
to Clinical Materials and has served as a speaker on related topics. As part of her role as Chair, she was
involved with the consolidation/globalization of the North American (CMC) and European (IMPG) COPs into the
Investigational Products COP. She has served on the ISPE Community of Practice Council and currently serves
on the Training Advisory Committee and Asset Integration Task Team. A member of the ISPE International Board
of Directors since 2006, Ms. Gore is affiliated with the Great Lakes Chapter.
Director: Tomiyasu Hirachi, EEM Japan CO., Ltd.
Mr. Hirachi is Representative Director and President of EEM Japan Co., Ltd.
For more than 35 years, he has been involved in engineering, production, project management, and factory
operation. Mr. Hirachi joined Sandoz Japan in 1989 and successfully completed the solid dosage form factory
expansion as well as grassroots construction of the research center project as a local project manager. He
was then responsible for Engineering, Production, and Head of Technical Operation Division, successively. In
1998, after the merger of Sandoz and Ciba-Geigy, he joined Shionogi & Co., Ltd. as president of Bushu
Pharmaceuticals Co., Ltd., pharmaceutical third-party manufacturing company newly created by Shionogi. He
played a leading role in establishing the company. In 2002, he was assigned as director and Settsu factory
manager of Shionogi & Co., Ltd. In 2004, he moved to Shionogi Qualicaps Co., Ltd. (now Qualicaps Co.,
Ltd.) as president. Mr. Hirachi established an engineering and factory operation consulting company in 2007.
He is one of the founders and the first Chairman of ISPE Japan Affiliate, and remains as a Director and as
Chairman of the Program Committee of the Affiliate. He is a former member of the ISPE Professional
Certification Commission and the International Leadership Forum. Mr. Hirachi has served on the ISPE
International Board of Directors since 2006.
Director: Stephen Tyler, Abbott Laboratories
Mr. Tyler is a Director of Strategic Quality and Technical Operations in Global
Pharmaceutical Operations at Abbott Laboratories, a worldwide-diversified health care company, in Abbott
Park, Illinois, USA. He received B.S.degrees in Applied Biology and Chemical Engineering from the Georgia
Institute of Technology, and a M.S. in Microbiology from the University of Georgia. Mr. Tyler joined the
Strategic Quality and Technical Operations organization in 2008. The Strategic Quality and Technical
Operations group provides strategic centralized technical support for data analysis, quality technology
transfer, risk assessment and management and development of enhanced quality systems. Previously he was
Director of Process Sciences and Engineering, an organization that provided technical support to Abbott's
drug product and substance manufacturing organization.
Director: Guy Wingate, BSc, MSc, PhD, GlaxoSmithKline
Dr. Wingate is currently Quality Director at GlaxoSmithKline and has 17 years
of experience working in the pharmaceutical industry. At GSK, he has had overall responsibility for quality
for one of GSK's largest manufacturing sites, responsibility for QA Technology Strategy, leading a major
revision to the GSK corporate Quality Management System, and overall responsibility for Computer Compliance
standards and implementation. Dr. Wingate has been involved with the GAMP COP for 15 years in various
capacities; most recently he has chaired its governing body GAMP Council since 2000 and led the Task Teams
producing GAMP®4, GAMP®5 and the GAMP® Good Practice Guide on Compliant
Electronic Records and Signatures. Currently he is Co-Chair of ISPE's Task Team writing a new
Baseline® Guide for the Science and Risk-Based Approach for the Specification, Design, and
Verification of Facilities, Utilities, and Equipment Systems which is based on ASTM E55 principles. Wingate
is a Chartered Engineer and holds a BSc, MSc, and PhD from University of Durham in computing, advanced
electronics, and engineering science respectively. He is widely published in journals and books, and
regularly chairs and speaks at conferences in the US and Europe. Dr. Wingate is also Visiting Lecturer for
the University of Manchester's M.Sc. course on Pharmaceutical Engineering Advanced Technology (PEAT) and
Dublin Institute of Technology's accredited MSc course on Validation Sciences.
Past Chair: Charles Hoiberg, PhD, Pfizer
Dr. Hoiberg is an Executive Director in Pfizer's Global Regulatory CMC group.
He received a BS in chemistry from the College of William and Mary and a PhD in biochemistry (chemistry
minor) from Pennsylvania State University. He worked for more than eight years at Sterling Drug Inc. in
R&D before joining the US FDA. Dr. Hoiberg had a leadership role and held numerous positions in the
Agency and was involved in many global initiatives. When he retired from the Agency, he was the Deputy
Director of the Office of New Drug Chemistry and the Associate Director for International Activities. He was
the CDER ICH Quality Coordinator and represented the Agency in negotiations of many ICH guidelines. He has
maintained close contacts with many worldwide regulators and industry leaders. While at the Agency, Dr.
Hoiberg was very involved in working with ISPE on developing the SUPAC Equipment Addendum. He has been a
frequent lecturer for ISPE at its domestic and international programs in Europe and Asia. Currently he is a
member of various ISPE Committees, including the Regulatory Affairs Committee, PQLI Steering Committee, and
the President's Advisory Council.