Compliance Architects^® was founded by Jack Garvey, a leading expert-attorney in FDA-regulated compliance, quality, operations and regulatory matters. Jack possesses close to 30 years of hands-on leadership experience at top-performing life science companies including Johnson & Johnson, C.R. Bard, Ciba-Geigy, BASF Corporation and Ayerst Laboratories.  Using both traditional and proprietary approaches to quality and compliance remediation, Jack expands upon traditional operational practices with pragmatic solutions that can reduce enforcement risk from today’s aggressive FDA.  A chemical engineer and attorney by formal training, Jack possesses the legal, regulatory and process expertise that allows him to excel at the complex interplay of science, law and business.

Through regular blogging, webinars, presentations and public speaking, Jack is known for his savvy, no-nonsense approach to FDA compliance and his ability to resolve the most complicated compliance and enforcement issues facing FDA-regulated industry, rooted in the belief that FDA enforcement risk can be mitigated – with hard work, sufficient investment and innovative approaches.

Jack’s Resume

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.

Jerry has been the COO of Compliance Architects^® since January 2013, following an impressive 24-year career with Accenture, where he was a Partner. Jerry has significant experience managing large, complex client service-delivery engagements with leading companies in the Life Sciences industry, including Pfizer and BMS. Jerry is responsible for all Compliance Architects^® client delivery outcomes, internal operational systems and controls, and managing customer satisfaction with all Compliance Architects^® engagements.

Jeff joined Compliance Architects® in January of 2019 as the Vice President of Business Development.  Jeff is a highly-regarded industry veteran with more than 20 years of experience as a successful team leader in building sales and marketing operations. Before joining Compliance Architects®, Jeff served as Director of Business Development at FDAnews. Prior to that, he served as Conference Director and was responsible for developing the FDAnews Inspections Summit – now in its 14^th year.

Michelle joined Compliance Architects^® after a successful 15 year career at Accenture where she was a consultant and Senior Human Resources manager. Her expertise includes HR operations and project management, process development, employee relations and coaching. Michelle manages recruiting and talent management activities and is responsible for personnel management and HR capability enhancement. In her role, she works closely with our individual consultants, clients and strategic business partners.

Beth Ritter supports Compliance Architects^® client operations and financial reporting. Beth is responsible for accounts payable, accounts receivable, cash management, process improvement projects, financial software support and consulting time and expense reporting coordination. Beth received her Bachelor of Business Administration in Public Accounting from Pace University.