Served/serving in the following positions as an industry volunteer and Subject Matter Expert (SME):- AI Community of Practice (CoP) / Steering Committee Secretary - 2024- Chair of GAMP Global Software Automation and Artificial Intelligence (SA&AI) Special Interest Group (SIG) 2019 to Current- Member of GAMP Council/Global Steering Committee / 2014 to Current- Member of GAMP Americas Steering Committee / 2010 to Current- Chair of GAMP Americas Steering Committee / 2016 - 2020- Vice Chair of GAMP Americas Steering Committee - 2014 / 2015- Co-Chair of GAMP Global R&D and Clinical Systems Special Interest Group (SIG) / 2010 - 2019- 2016 & 2017 ISPE Annual Meeting Track Director for IS/GAMP Community of Practice (CoP)- Member of ISPE Knowledge Network Council - 2015 / 2016Recent Presentations:- Webinar: AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment - March 8th, 2024- Annual Meeting (Las Vegas, NV) – Oct. 17th, 2023 Topic: Leveraging ML for Process, Efficiency, and Compliance- GAMP Forums (Jersey City, NJ & Indianapolis, IN) - June 13th & 15th, 2023- Annual Meeting (Orlando, FL) – Oct. 31st, 2022 Topic: GAMP5 2nd Edition Roundtable (AI/ML)- Annual Meeting (Boston, MA) – Nov. 1st, 2021 Topic: Applying a GAMP5 Framework to AI/ML- Annual Meeting (Virtual/Remote) – Nov. 6th, 2020 Topic: Data Integrity for Machine Learning (ML) – A Data Life Cycle Model- Annual Meeting (Las Vegas, NV) – Oct. 27th, 2019 Topic: AI & Machine Learning – Basics and Best Practices- Annual Meeting (Philadelphia, PA) – Nov. 6th, 2018 Topic: Engaging Patients and Collecting Clinical Trial Data in a GAMP Compliant Manner- Annual Meeting (San Diego, GA) – Oct. 30th, 2017 Topic: The ART of Efficient and Effective CSV

- Led a team of professionals responsible for the quality management of GxP Cloud based services (i.e., XaaS) for 100+ pharma/bio-tech clients. Included the oversight for IaaS/PaaS compliance to FDA/EMA/MHRA regulations, responsibility for the organization’s entire Quality Management System (QMS), ISO27001 & ISO9001 certifications, and support of client regulatory inspections.

- Led a global team of 25+ professionals providing consultancy, independent quality oversight, and on-going compliance monitoring (CSV/CSA) of Signant Health's core products and client implementations (SaaS), business-critical systems, and digital technology solutions.- Responsible for the organizations QMS, performance of internal quality audits, inspection readiness assessments, conduct of vendor / supplier qualification activities and hosting of client / customer audits.

- Led a global QA & compliance team responsible for the GXP compliant delivery of Artificial Intelligence (AI) / Machine Learning (ML) solutions geared towards Pharmacovigilance (PV) for several large/top-tiered pharmaceutical companies. Team included traditional QA (ex. QMS / GXP & SOC2 Compliance), Quality Oversight (Client / Project Focused Quality), and Quality Management (i.e. Software Life Cycle / SDLC & Validation Expertise).- Interacted closely with clients/customers and internal business partners for RFPs, system implementations, due diligence reviews, and the hosting of audits. - Managed all controlled documentation (ex. policies, procedures, etc.), deviations / CAPAs, internal training program, client audit / inspection preparedness, vendor / supplier audit program, oversight of software validation (SDLC) and infrastructure qualification (IQ/OQ), risk management, privacy - PI/PII (GDPR), and process improvement.- Led and managed the PVAI (Pharmacovigilance Artificial Intelligence) organizations obtainment of their first SOC2 Type II report / attestation.- Integral team member to develop and implement an AI Development Life Cycle in alignment with regulatory guidance (FDA), regulator involvement (MHRA), and industry consultation.

- Head of Technology & Information Quality (TiQ), providing cross-functional digital expertise and serving as the primary global resource supporting all areas of technology / information delivery and compliance.- Responsible for the corporate culture and organizational maturity of several tech entities (ex. Parallel6 / Nextrials), and their successful integration into the business.- Accountable for providing global compliance leadership to technology and data integrity initiatives, allowing for their effective and efficient implementation.- Recognized with President's Award in 2018 for outstanding leadership and innovation.

- Led a global team of 60+ professional level staff in more then 12 countries; included the identification, recruitment and development of senior level international resources.- Responsible for the creation, implementation, and active management of the department's communication plan, in addition to monthly metrics (KQIs) and performance dashboards.- Served as the lead and point-of-contact (PoC) for several large company partnerships and due diligence reviews.- Responsible for the following GXP global audit areas / programs: clinical sites, vendors / suppliers, PV, country / regional office operations, and IT systems.- Actively managed regulatory inspections (FDA, EMA, & MHRA) for PRA HS and sponsors / clients.- Served as 'Program Lead' of QA operations inclusive of departments annual budget, recruiting, performance metrics / dashboards, communications, IT tools and databases for audit program, document management, CAPAs, process deviations, and corporate investigations.- Developed and led the creation of a 'Systems Compliance Team' in charge of actively managing the compliance of companies IT (GCP) and laboratory computerized systems (GLP).- Involved in the conduct of internal audits, sponsor audits, and corporate compliance investigations.

- Led a team responsible for IT process (ITIL) / procedures, computer systems validation (CSV), quality systems & metrics, audit support, and client requests for information / proposal (RFI/RFP).- Restructured the IT quality management system (QMS) and associated procedures to better align with industry guidance and best practices (ex., GAMP5).- Led all quality and compliance related aspects of IT departments processes including change control, incident and problem management, CAPA, disaster recovery (DR), records retention, document control, training, audit support and response, computer systems validation (CSV), and software development life cycle (SDLC) activities. - Developed policy relating to IT security and acceptable use of systems.- Interacted closely with business QA and strategic solutions to provide IT feedback and responses to client requests for information. - Developed and reported monthly quality metrics to efficiently communicate compliance status of department to executive management, including the CIO, in addition to the IT leadership team.

- Led a global organization of 30+ employees and contract staff in support of IT quality related services, as well as both on-shore and off-shore test teams. - Restructured department in terms of staffing and process management in order to more efficiently and effectively meet existing and long term needs of the organization.- Responsible for the global leadership and strategic implementation of IT Computer Systems Validation (CSV) across all GXP business units.- Owner of the IT SDLC along with its continued development, improvement, and overall efficiency.- Actively recommended and provided proper quality controls for computer systems to ensure the reliability of applications, integrity of data, and safety of patients. - Provided direction to ensure that IT applications and infrastructure components possessed the necessary level of testing, and required documentation to comply with applicable FDA GXP regulations. - Ensured the uniformity and harmonization of IT compliance related matters across international locations including England, Germany, and France.- Responsible for protecting IT assets from regulatory and client scrutiny.- Interacted closely with business unit colleagues, IT partners, and external agencies such as FDA and MHRA.

- Led the global quality improvement and process harmonization of R&D quality systems (GMP / GLP / GCP), managed the QA IT portfolio, developed global quality directives, and established metrics / KPIs to drive and monitor process excellence.

- Developed and led groups consisting of sample management, data audit / QC, systems validation, and LIMS administration & interfacing.

- Responsible for staff and activities relating to laboratory systems compliance / validation, technical writing, and internal auditing.

- Managed contracts and led project teams to qualify and validate laboratory systems in support of R&D operations.

- Provided validation services for various clients relating to laboratory systems, automation, and information technology (IT).Clients included Aventis Pasteur, GSK, and Purdue Pharma.

- Provided quality assurance support and regulatory guidance to product development and manufacturing operations for the production of medical devices.

- Conducted various QC laboratory tests, and led qualification / validation efforts of investigational product, equipment / instruments, and COTS software packages.