Acting as the Tarrytown, Sleepy Hollow, Basking Ridge site lead for QA Validation. Overseeing:- Equipment Qualification: Quality oversight of activities associated with laboratory equipment qualification, including change control and periodic evaluation. Also responsible for the program management. Quality oversight of research method validation reporting.- Computer System Validation: Strategy development, project planning and project management for CSV activities and deliverables, and review/approval of CSV related documents, including change management and periodic evaluations- Management of IT Quality Audit division of GMP Auditing. Responsible for conducting audits of IT Suppliers/Vendors. Act as IT SME for GCP, GLP, and PV audits.

Site QA Validation Lead, Tarrytown, NY- Equipment Qualification: Oversight/execution of activities associated with laboratory equipment qualification, including initial and continuing qualification- Computer System Validation: Strategy development, project planning and project management for CSV activities and deliverables, and review/approval of CSV related documents, including change management and periodic evaluations- Management of IT Quality Audit division of GMP Auditing. Responsible for conducting audits of IT Suppliers/Vendors. Act as IT SME for GCP, GLP, and PV audits.

Site QA Validation Lead, Tarrytown, NY- Equipment Qualification: Oversight/execution of activities associated with laboratory equipment qualification, including initial and continuing qualification- Computer System Validation: Strategy development, project planning and project management for CSV activities and deliverables, and review/approval of CSV related documents, including change management and periodic evaluations- Also continued participation in the conduct of IT vendor audits.

Focused mainly on laboratory systems:• Acts as quality assurance representative for Tarrytown IT change controls, reviewing and approving the change request and the change documentation.• Manages equipment qualification and change control program for affected departments as identified in the Tarrytown Master Plan• Acts as quality assurance representative for computerized systems validations at the Tarrytown site, reviewing and approving validation documentation.Also continued participation in the conduct of IT vendor audits.

• Schedule, prepare and conduct audits in support of GCP, GLP and/or GMP as directed. • Conducts audits in accordance with Regeneron standard operating procedures and quality policies. • Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations.• Exercises judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance.• Appropriately escalate any compliance issues. • Communicates audit results to management and auditees through written audit reports.• Manage post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts.

Responsible for coordinating, executing, and reporting internal and external audits and compliance in accordance with regulatory standards.• Initiation of all IT Questionnaire audits and review of responses, assessing for compliance. Followed up on deficient answers. Tracked status on the approved vendor list (AVL).• Participated in GMP/GLP audits for external vendors for raw material manufacturers, CROs, and contract laboratories.• Led GMP/GLP audits for external vendors for contract packaging, labeling and supply management of clinical materials, contract laboratories, and returned goods and service providers.• Participated in internal GMP/ISO audits of Materials Management, Pharmaceutical Analytics, Commercial Manufacturing, Clinical Manufacturing, and Quality Systems functions.• Led GMP/ISO internal audits of the Calibration Program, Quality Control, Warehouse Operations and IT departments.• Participated in internal and external GLP data audits.• Participated in the review of data presented in the NDA submission for Afressa®.• Participated as a member of the PAI team and worked with the FDA during the 10-day inspection as a runner, retrieving and verifying documentation according to their requests.

Responsible for providing computer systems validation expertise to project managers and quality oversight of project documentatation. Also to effectively identify, analyze and translate business needs into technology and process solutions.• Participated in the validation and implementation of Empower 2 Chromatography Data System.• Ensured project compliance with relevant GxPs including 21 CFR Part 11 and relevant site SOPs.• Developed validation documentation, including test scripts, when required.• Performed Risk Assessments for determining the level of validation required.• Developed IT standard operating procedures for System Lifecycle Management and for the Maintenance and Control of the IT Infrastructure• Participated in the qualification effort for the Network Infrastructure

Provided project management for the validation and implementation of computerized systems• Managed projects according to a software development lifecycle methodology.• Ensured project compliance with relevant GxPs including 21 CFR Part 11 and relevant site SOPs.• Authored project documentation.• Successfully completed the validation and implementation of Prime Technologies’ ProCal V5, a system for the management of inventory and calibration and preventive maintenance scheduling of instruments and equipment.• Effectively trained users and project members on the use of ProCal V5.• Authored the training manual for the use of ProCal V5.• Initiated the validation of Clinical Systems, Inc’s CLINPRO / LBL v7.01, a system used for the generation and printing of labels for clinical and non-clinical supplies and the generation or importation of patient and material randomizations.

Responsible for developing, creating, and coordinating the execution of validation protocols and test scripts for computerized systems projects.• Ensured documentation and testing compliance with relevant GxPs including 21 CFR Part 11 and relevant site SOPs.• Prepared Aris process models for the Drug Development Phase I-IV Process Improvement Team• Led new User Requirements gathering initiative for the LIMS upgrade project. Created program and conducted ‘Gathering and Writing User Requirements’ training for 20+ people. • During restructuring of the company, took on the role of project manager to complete the validation and implementation of validation projects.• Edited and/or authored over 100 validation test scripts.• Trained testers on the proper procedures for executing test scripts.

Responsible for administrating and coordinating the stability program, reference standard program, and the analysis requests system.• Authored SOPs pertaining to the administration of the stability program, reference standard program, and the analysis requests system.• Trained the Pharmaceutical Analysis department on SOPs pertaining to the administration of the stability program, reference standard program, and the analysis requests system.• Participated as a team member of the gLIMS project, the first successful implementation of a laboratory information management system at the R&D site.• Served as team leader for SOP sub-team of gLIMS project, assuring all proper SOPs were drafted or edited and approved prior to completion of project.