BOARD OF DIRECTORS
Ben Lee PRESIDENT
P.Eng, B.Sc., I.E.
Principal I Director Business Development
Stantec
Ben Lee brings over 25 years of experience in all aspects of Project Management. He has successfully delivered over $1B in major projects in the biotechnology, pharmaceutical, hospital and manufacturing sectors from concept to completion.
Mr. Lee has comprehensive knowledge and practice of current GMP, GLP, FDA and CFR 21 Part 11. He possesses direct and extensive experience in project planning such as benefit-cost analysis, life cycle costing, feasibility studies, change control, operational/technical requirements, analysis & optimization, functional/space programming, land use and environmental approvals. Mr. Lee has been invited to speak at several associations, including the ISPE conference as a keynote speaker.
David McSweeney VICE PRESIDENT
B.Sc, AIT
President
QIE Consulting
KAJAL PALAN TREASURER
CPA, MBA, MMA
VP Finance & Strategy, Global Operations
Apotex Inc.
Kajal has more than 20 years of financial leadership experience in the pharmaceutical industry. He is currently VP Finance & Strategy, Global Operations at Apotex, a Canadian pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Kajal is a Chartered Professional Accountant. He also attended Queen’s University and graduated with an Executive Masters in Business Administration, and more recently a Masters in Management Analytics.
JOAN Bevilacqua Secretary
MBA Business, B.Sc. and M.Sc. Microbiology
AvP, Global Head CMC Strategy & Execution
Sanofi
Joan Bevilacqua has more than 30 years of experience in the pharmaceutical industry, specifically in Vaccine development and licensure. Currently she is the AvP, Global Head CMC Strategy & Execution, Sanofi. Her career has spanned across several vaccine areas, and has included roles in analytical strategy and development of new analytical methods in Quality Control and in R&D as Head of Analytical Research & Development North America, in Clinical Development, and as Global R&D Project Leader. As Global Project Leader, she has successfully led seven new vaccine license submissions in Canada, US , and Europe. Over the years, she has had direct experience in cGMP, cGLP, cGRP, and in strategic lifecycle management of the vaccines globally. As a seasoned leader at Sanofi, Joan has had the opportunity to be involved in the design and delivery of a number of strategic corporate business simplification and efficiency programs as well in a several employee development initiatives, in addition to being an employee mentor/coach and a member of the Joint Labour Management Committee.
Manny Papadimitropoulos BOARD MEMBER
B.Sc. Chemistry, B.S.P. Pharmacy, M.Sc.Phm. Pharmacy, Ph.D.
Senior Director RWE International – Immunology
Eli Lilly & Company
Manny Papadimitropoulos graduated in Pharmacy from the University of Saskatchewan and has worked in retail pharmacy, the pharmaceutical industry, and academia over the last 25 years. His pharmacy experience has been primarily in health economics, and clinical research. He has a master’s in Pharmacy and a Ph.D. in Health Economic Evaluation from the University of Toronto in Canada. Manny is currently the Senior Director RWE International – Immunology at Eli Lilly and Company. He is also an adjunct assistant professor at the University of Toronto, Faculty of Pharmacy, in the Administrative/Social Pharmacy area. Manny’s areas of research are in HTA and decision analysis, and is a supervisor of four graduate students.
Mladen Danon BOARD MEMBER
P.Eng., MBA
Quality & Continuous Improvement Head
Mid-Day Squares
Mladen Danon received his Engineering bachelors from the University of Toronto, Masters in Business Administration from Schulich Business School and he is a licensed engineer in the province of Ontario. Mladen has experience in both Oral Solid Dose and Sterile GMP manufacturing at branded and generic pharmaceutical firms. Mladen has held several roles throughout his career in the fields of Project engineering, Commissioning/Qualification, CSV, Contamination Control, Quality Operations and Strategic Planning. He is currently the Quality and Continuous Improvement at Mid-Day Squares.
Mladen has a strong passion in working cross-functionally with his peers to drive alignment, change and positive disruption in an effort to reduce waste and improve value generated for customers/patients.
Yuan Fang BOARD MEMBER
Ph.D. MBA P.Eng RAC
Abbott
Divisional Vice President for Corporate Global Strategic Regulatory
Yuan serves as the Divisional Vice President for Corporate Global Strategic Regulatory at Abbott and served as a member of the Board of Directors of several private medical device companies. Yuan worked in industry in a variety of roles, such as VP of regulatory affairs, quality and manufacturing, Head of Regulatory Policy, Director of Global Regulatory Affairs and Director of Design Quality Engineering. Yuan worked at the U.S. Food and Drug Administration for 8+ years, and as the acting Branch Chief and team lead, he led multidisciplinary review teams for 150+ medical device premarket submissions (including PMA, IDE, 510(k) and 513(g)) and 100+ compliance assignments (inspections, warning letter resolutions, recalls, ARO and trade complaints). Yuan received the prestigious FDA Outstanding Service Award for his contributions and expertise in Total Product Life Cycle (TPLC) management and the lead author on the FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices. Yuan received his PhD majoring in Electrical Engineering from the University of Waterloo, MBA from Ivey Business School – Western University, and is a licensed Professional Engineer (P.Eng) in the province of Ontario.
Mohamad Ahmad BOARD MEMBER
Vice President, Quality and Compliance
Biological Manufacturing Center (BMC)
Mohamad Ahmad is the Vice President of Quality and Compliance at BMC, where he oversees the organization’s quality functions, ensuring adherence to industry standards and regulations. In his role, he leads cross-functional teams dedicated to driving operational efficiency and quality excellence. He was promoted to Vice President in April 2024, after serving as Director.
With over 15 years of experience in the pharmaceutical industry, Mohamad has developed a strong leadership track record, specializing in building and managing high-performing teams. His leadership has been crucial in establishing BMC’s quality control department from the ground up, fostering a culture of continuous improvement, adaptability, and a commitment to meeting the evolving needs of the business.
Mohamad holds a Bachelor of Science in Biochemistry from Concordia University. He is known for his ability to translate technical expertise into practical solutions that align with business goals and drive organizational growth.
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Paul Gustafson BOARD MEMBER
Senior Corporate Regulatory Compliance & Enforcement Adviser
Health Canada
Paul Gustafson brings over 26 years of experience taking on various roles within the pharmaceutical sector. Paul is currently a Senior Corporate Regulatory Compliance and Enforcement Advisor at Health Canada with 16 years of experience as a regulator in the field of good manufacturing practices (GMP).
Paul also holds Executive Bureau positions with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) where he is currently the Deputy Chairperson and Chairperson for the Sub-committee on Harmonisation of Good Manufacturing and Distribution Practices (GMDP). PIC/S is a non-profit association registered under Swiss law that leads the international development, implementation, and maintenance of harmonized good manufacturing practices (GMP) standards and quality systems of Inspectorates in the field of medicinal products.
Within the pharmaceutical private sector, Paul’s 10 years of experience included positions in analytical chemistry, quality assurance, and senior management.
Miruna Bala BOARD MEMBER
P.Eng, PMP
Head of Quality and Regulatory Affairs
Genome Sciences Centre, CFIL-Deeley Research, BC Cancer
Miruna Bala is currently the Head of Quality and Regulatory Affairs at the Genome Sciences Centre, CFIL-Deeley Research, BC Cancer. She is a qualified Professional Engineer and certified project management professional. Miruna is a certified College of American Pathologists (CAP) and ISO lead auditor (BSI).
At CFIL, Miruna provides quality and regulatory affairs leadership for the development of clinical trial applications. She is experienced in CTA and NSN regulatory submissions to Health Canada.
At the GSC, Miruna is responsible for bringing key quality programs, Change Control, Audit, Validation, Document Control, and CAPA programs into compliance with various accreditation standards. She has successfully led the GSC through CAP and ISO accreditation inspections since 2011.
Miruna brings over 20 years of QMS expertise in the genomics, biotechnology, cell therapy, and nutritional supplement industries with extensive knowledge in CAP, DAP, GMP, ISO 9001, ISO 27001 and CLIA standards. She holds a Bachelor of Applied Science Degree in Biological and Process Engineering from the University of British Columbia and a Masters Certificate in Project Management from the Gustavson School of Business, University of Victoria.
Liane Smith BOARD MEMBER
M.Sc., PMP
Executive Scientific Advisor
Liane Smith is an experienced senior leader with global expertise in the biopharma industry and extensive knowledge in vaccine manufacturing and chemistry and manufacturing controls. She has proven strengths in operations management, technology innovation and business development. She is well known for her collaborative and quality-minded approach. As Director General for the newly built Biologics Manufacturing Centre at the National Research Council of Canada in Montreal she was responsible for operationalizing the end-to-end facility. Prior to this role, Liane worked at a contract manufacturing organization where she directed manufacturing science, technology transfer and validation functions. Previously, Liane held a number of roles at Sanofi including Senior Director of Global Technology Innovation, where she worked on identification and evaluation of new delivery devices. At Sanofi, she also worked on many early and late stage vaccine projects and had responsibility for manufacture of several licensed vaccines. Liane’s global experience includes consulting at WHO meetings on the use of patch delivery systems for vaccines.
Jeff Hartry BOARD MEMBER
Director of Quality
IVC Vita Health
Jeffrey Hartry is a 30 year veteran if the pharmaceutical and biologics industry. He is currently the Director of Quality at IVC Vita Health. Jeffrey has responsibilities for all Quality operations covering the Quality Control Laboratory, Method Development, Quality Assurance, Quality Compliance, Stability and Validation activities.
IVC Vita Health is located in Winnipeg, is a diversified health products company involved in the development, manufacturing and distribution of pharmaceuticals, nutraceuticals and dietary supplements for the Canadian Market.
Prior to joining Vita Health Products, Jeffrey consulted for a number of years, working numerous projects for clients in Asia, India, Europe and the US. He held positions of Director of Quality Systems and Information and prior to this, Director or Quality Assurance at Cangene Corporation. Responsibilities encompassed corporate quality systems and company information management programs and practices and responsible for all quality activities for manufacture and plasma operations respectively.
Mr. Hartry career began conducting research in the Department of Chemistry at Queen’s University at Kingston where he received his BA and B.Sc.(Hons) in Chemistry. Mr. Hartry began his pharmaceutical career working in cardiovascular drug research for the Heart and Stroke Foundation and later Ciba-Geigy. Mr. Hartry then moved on to work with Toronto Research Chemicals before eventually moving west to continue his career advancement in Manitoba through series of progressive roles with, Winnipeg based, Apotex Fermentation,
Brooke Schooley BOARD MEMBER
M.B.A, BSc.
Vice President, Quality
Catalent Consumer Health
Brooke Schooley has over 20 years of Quality management experience with global contract development & manufacturing expertise in the pharmaceutical and consumer health industry.
With an extensive background in the application of continuous improvement strategies to streamline both the compliance aspects and efficiency needs of the Quality System within the world of contract manufacturing, Brooke is well known for her leadership capabilities and facilitation of change management, as well being a champion of customer experience excellence and the optimization of new product introduction initiatives.
Brooke currently holds the position of Vice President, Quality for the Catalent Pharma Solutions Consumer Health business unit, leading global quality operations in Canada, United States, Latin America, and Europe. Utilizing and emphasizing the importance of a Patient First approach, Brooke leads all aspects of the Quality System governing the development and commercial manufacturing, packaging, and distribution of pharmaceuticals, nutraceuticals, and dietary supplements in various markets across the globe.
Prior to joining Catalent Pharma Solutions, Brooke held several Quality and Compliance leadership positions of increasing responsibility at Canadian contract manufacturer Accucaps Industries in Windsor, Ontario.
Brooke earned a Bachelor of Science Degree in Biological Sciences and a Master of Business Administration from the University of Windsor.
Max Zive EX-OFFICIO BOARD MEMBER, ADVISORY BOARD REPRESENTATIVE
B.Sc. Pharm. D.T.M.
President
Zipharm International Inc.
Max was the past acting Executive Director of the PSG and has been involved on numerous duties including Chairman of the Annual Conference and Training committees as well as provided office admin support for over 17 years. He recognized the vital need for and importance of quality training in the pharmaceutical industry and has continually devoted himself towards achieving this important goal.
As a pharmacist/entrepreneur, Max was President and founder of Genpharm Inc, a major pharmaceutical company located in Toronto, which affiliated with an international group of major pharma companies located in England, Ireland, Australia, New Zealand and Europe. He is also the president/founder of Zipharm International Inc., a pharmaceutical industry consulting company located in Toronto, which provides specialized services to the Canadian and International pharmaceutical industry relating to all Regulatory, Government and corporate, and business affairs.
With a passion for promoting the well being of disadvantaged people globally, he has been extensively involved in meaningful humanitarian activities and has provided significant supplies, medicines, and life saving humanitarian needs to third-world countries including Africa, Europe, and Asia, valued at over $65 million USD. These contributions include sizable donations to the Red Cross in North and South Vietnam for four consecutive years. The most recent donation consisted of a container of significant hospital supplies to the Ministry of Health of the Seychelles.
Max was the recipient of the Pharmaceutical Sciences Group (PSG) “Lifetime Achievement Award for Outstanding Services to Life Sciences” and Toastmasters International Distinguished Toastmaster (D.T.M.) award in “Leadership & Communication.”
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