Teresa Gorecki

Practice Director

Teresa Gorecki comes to Compliance Architects® from Johnson & Johnson,…

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, and 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 leas J&J subject matter expert in handling FDA inspections (routine, special cause and PAl) for Cosmetic and Consumer, CombinationDrug/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.