Professional Experience
The FDA Group LLC, Westborough, MA 10/2020 – Present
Industry Consultant
Responsible for conducting a due diligence audit for one client and supporting a second through an on-going recall
Henry Schein Inc., Melville, NY 9/2016 – 6/2020
Senior Director, Quality Assurance and Regulatory Affairs – International and Joint Ventures
Developed, implemented and managed continuous quality improvement strategies, policies and processes for all international and joint venture facilities. Worked closely with international and joint venture Quality and Regulatory teams, as well as with business team leads to ensure that company wide compliance metrics were achieved. Managed 20+ direct and indirect quality professionals located both domestically and internationally including identifying headcount needs, staff development, job descriptions and budget.
- Implemented Quality Management Systems at several US and UK facilities including bringing one facility into cGMP compliance within nine months.
- Assumed responsibility for licensure and registration of domestic and international facilities assuring that all facilities remained in a state of compliance including streamlining and formally documenting operations to enhance capabilities.
- Served as strategic advisor to harmonize quality and regulatory policy and procedure implementation, and support government audits thereby minimizing the likelihood of adverse audit findings.
- Provided Quality and Regulatory leadership to Henry Schein Inc. joint ventures to ensure ongoing compliance with FDA and international requirements.
- Key member of the Animal Health spin off team (netting the organization $1.25 bn), providing guidance on post spin structure of the new entity as well as advising the team on quality, regulatory and licensure issues and mitigation strategies.
- Successfully led a multinational team to bring EU entities into compliance with the Falsified Medicines Directive and the Medical Device Regulations allowing continued operations within the EU.
- Performed Quality and Regulatory due diligence assessments and audits in support of Henry Schein Inc. acquisition allowing the company to assess potential cost impact to bring the entities into compliance.
- Led site remediation efforts to bring about a successful site transfer audit and expansion of scope to the ISO 13485 certificate of a US based site to include new medical devices while implementing changes to the Quality Management System.
Fougera: A Sandoz Company (Altana Inc./Nycomed US Inc), Melville, NY 5/2004 – 9/2016
Associate Director, Quality Systems and Compliance/FDA Liaison
Managed the relationship between the organization, the FDA and other governing organizations. Led numerous FDA (both cGMP and PAI) audits and other internal and external audits and drafted responses to same. Chaired the Site Quality Council, managed the in-process and finished product Quality Assurance function. Managed complaints, deviation investigations, laboratory investigation and CAPA processes.
- Managed eight FDA inspections with minimal (i.e., four or less) minor observations noted.
- Wrote and implemented Fougera Quality Manual and Fougera Business Continuity Plan to bring the organization into compliance with Sandoz/Novartis requirements.
- Developed and implemented Annual Site Quality Plans.
- Developed Site Master File for two locations.
- Revised product recall procedure to streamline operations, reduce costs and strengthen compliance.
- Managed Supplier Quality Process including API, excipient, packaging and service providers including both paper and on-site audits of suppliers.
Associate Director, Quality Systems and Compliance/FDA Liaison, continued
- Managed all Field Alert Reporting and Recalls including compliance with all FAR reporting requirements and the initiation and closure of numerous recalls/market withdrawals all in full compliance with governing regulations.
- Oversaw the internal audit program to ensure compliance with both FDA regulations and Sandoz/Novartis requirements.
- Enhanced and streamlined the CAPA system reducing the CAPA backlog and quicker implementation of corrections/enhancements to the Quality System.
- Developed and implemented procedures to enhance product development and clinical operations resulting in enhanced compliance, reduced development times and successful launch of new products.
- Streamlined QA operations to support a 40% increase in through put without an increase in headcount or compromise in quality.
- Enhanced the Annual Product Review process to allow for the early detection of negative trends and implementation of proactive steps.
- Reduced batch record review backlog by 85% in two months.
- Established departmental budget and headcount needs.
- Developed career paths for the entire QA Organization to include job descriptions and a clear path for advancement through the department.
Additional Relevant Experience
Olympus America Inc. (“OAI”), Melville, NY
Senior Manager, Regulatory Affairs/Quality Assurance
Established a Quality system that ensured Regulatory (i.e., FDA) compliance and increased Quality awareness
within the organization and supported business objectives. Oversaw internal audits of the Quality performance
of the Medical Systems Operating Group. Managed Labeling generation/review process. Led ISO 9000
awareness efforts. Supervised FDA submission (510(k)) activities. Coordinated corporate-wide OSHA compliance.
Manager, Corporate Quality Assurance
Led the establishment a Corporate-wide Quality system.
Advanced Interconnection Technology, Inc. (formally PCK Technology division of Kollmorgen)
Product Engineer
Generated, tracked and drove to conclusion all activities associated with customer quotations.
Quality Assurance Engineer
Implemented a DoD compliant Quality system.
Education / Continuing Education
Bachelor of Science (B.S.) in Bio-Medical Engineering, New York Institute of Technology
EU MDR auditor Training, Oriel/Stat-A-Matrix, 11/2019
Doug Conant Leadership Bootcamp, 11/2019
EU MDR Training, RAPS, 12/2018
ISO 13485:2016 Lead Auditor Training, Oriel/Stat-A-Matrix, 12/2017
HIPAA Security Rule, HIPAA Academy/Mercer University, 1/2004
HIPAA Privacy Rule, AdvaMed, 4/2002
Internal Auditing for ISO 9000:2000, Stat-A-Matrix, 5/2001
Corrective and Preventive Actions, AdvaMed, 4/2001
Quality System Inspection Techniques, ASQ, 6/2000
Professional Organizations
Member, American Society for Quality (ASQ)
Member, Regulatory Affairs Professional Society (RAPS)
Former member, AdvaMed (Formally HIMA), Medical Technology Learning Institute Advisory Board
Former member, The Association for the Advancement of Medical Instrumentation (AAMI)