Issues, Trends, Excitement, and Great News for Pharmaceutical Manufacturers — A Conversation with Teresa Gorecki of Compliance Architects

The bluEPrint by Executive Platforms

At the 2024 edition of the Pharma Manufacturing World Summit we sat down with Teresa Gorecki of Compliance Architects to speak with enthusiasm and optimism about the future of medicine, the most recent developments and what they mean for patients, but especially the most recent ideas and information pharmaceutical manufacturers and other senior leaders in the Life Sciences need to know as the industry moves forward together into a very exciting time. What are some of the top-of-mind challenges and opportunities pharma manufacturers are dealing with right now, and how are the early adaptors already addressing those issues? How are regulators working with industry to improve end results for patients? How is commercialization of ATMPs progressing, and what can we all learn from the first examples coming online now? For all this and more, give this episode a listen!

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Teresa Gorecki comes to Compliance Architects® from Johnson & Johnson, Janssen Pharmaceuticals, where she was most recently Vice President, Market Quality. At Johnson & Johnson, Teresa was one of J&J’s top Quality professionals, known for her ability to manage inspections and remediate and improve deficient operations. Teresa had senior level roles across all three sectors within Johnson & Johnson: Pharmaceuticals, Consumer Products and Medical Devices.

Teresa is one of Compliance Architects’® lead subject matter experts, and has primary responsibility for strategic client engagements.

At Johnson & Johnson, Teresa’s key accomplishments included:

· Chair of Johnson & Johnson Cross Sector Business Quality Governance Team responsible for developing a Governance Model and Organizational Structure to develop and oversee an aligned Quality Management System, Processes and Procedures across the J&J Enterprise Business/Marketing Company Quality Units.

· Member of J&J Company Leadership Teams/Boards including Regional Management Board for North America; J&J Consumer Healthcare Company (CHC) Board; and Neutrogena Management Board.

· Management of all aspects of Quality Systems, Quality Assurance, and Regulatory Compliance with Worldwide Regulatory Authorities including FDA (CBER, CDER and CDRH), MHRA,EMA, ANVISA, CFDA, Health Canada, etc. Extensive experience in combination products, pharmaceutical dosage forms for both OTC and Rx products; biological (r­ DNA and monoclonal antibody) products and a wide range of consumer products (class I and II medical devices, OTC drugs, cosmetics and consumer products) in the US and Puerto Rico.

· Over 20 years’ experience and lead J&J subject matter expert in handling FDA inspections (routine, special cause, and PAI) for Cosmetic and Consumer, Combination Drug/Device, Pharmaceutical, and Biological products.

· Extensive experience with new product introduction; product and technology transfer, and commissioning of new/re-constructed facilities.

· Leadership of ERP System (SAP) implementation for Pharmaceutical Sourcing Group of the Americas Sites in New Jersey and Puerto Rico. Management of large-scale Supply Chain projects for “Demand Pull,” or LEAN Manufacturing. Sponsorship of Six Sigma initiatives in Manufacturing and QA, which increased quality and compliance and yielded business benefits.

Teresa received her B.S. in Microbiology, with a minor in Chemistry from South Dakota State University.
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Compliance Architects LLC delivers high-value compliance, quality, and regulatory consulting services to companies directly regulated by the U.S. FDA and other global regulatory authorities. With capabilities ranging from quality systems implementations to audits, inspection