Manage and Lead Automation Quality and continuous improvement project portfolio with responsibility for defining strategy, coordination, planning, & execution. Serving as intermediary between clients/stakeholders and team members to ensure all project requirements, risks and deliverables are identified, integrated and tracked throughout project lifecycle, from initiation through closure to ensure timely completion and success. • Develop integrated project plans, schedules, identify and track milestones, risk analysis/management, resource and budget management, meeting excellence (scheduling, agenda development, minutes, action items), managing project communication to stakeholders and team members. Providing oversight, identifying trends and reporting to ensure successful project delivery.Notable Achievements:• Directed the successful FDA & MHRA Observation resolution at Regeneron Ireland and USA sites for establishing risk-based Audit Trail review frequency for user’s ability to hide or manipulate data which resulted in 75% reduction in Data Integrity investigations for QC Lab & Manufacturing. • Led and manage Regeneron FDA Observation for the identification of current Admin vs User activities risks. Identified and implemented controls for IOPS Ren and Raheen QC and Mfg systems resulting in clean audit. • Manage the successful implementation and upgrades for Raman synTQ, SoftMax, LabX systems.

Various leadership roles for a national corporation that provides Project Management, Quality, and operations services to clients in the Biotechnology/ Pharmaceutical sector. Manage and oversee global quality and compliance projects for the Fortune 100 clients like Regeneron Pharmaceuticals, Baxter Healthcare, and Pfizer Inc.

Provide strategic planning and project leadership to the Quality team, steering the operations of up to 10 team members, including building the team as needed to effectively manage a diverse range of projects. Notable Achievements:• Managed the successful completion of data migration, implementations and upgrades of 75 systems and equipment for Baxter-Baxalta Separation activities, including but not limited to LIMS (clinical operations), Clinical Trials management System (CTMS), Merge Electronic Data Management System (EDMS) and electronic Trial Master File (eTMF), Doc Compliance, and BMRAM. • Managed $25M project to restructure IT systems that resulted in a clean FDA Audit —including conducting risk analysis and assessment to finalize System inventory, conducting gap analysis and resolving issues, creating remediation plan, and delivering continuous process improvements to prevent future issues.• Led FAS (Field Application System) CAPA project to identify gaps across in-house developed FAS system after a previous FDA audit resulted in a quality gap finding, collaborating with approximately 30 people including project managers, business owners, and SME to evaluate, identify and execute corrective actions - personally-identifying 45% of the required corrective measures, resulting in a clean audit and CAPA closure.• Led QA audit defending 5 projects, ensuring compliance to prevent consent decrees and warning letters.

Provide QA-Validation oversight to support cGMP systems / programs in accordance with cGMP regulations and current industry-standard practices. Partnered with cross-functional groups and Project Managers to provide validation activities in support of GMP work, determine project priorities, and track progress.Notable Achievements:• Led $16M Product Registration Tracking and implementation project for Aris G. Register® from Validation perspective and responsible for collaborating with 20 people, including cross-functional teams, SMEs, business owners, testing team and an overseas vendor.• Delivered 25% reduction in testing time and 15% cost reduction by developing an improved Testing Strategy and Defect Management process used in 10 projects with 100% success rate that streamlined testing methodology and improved project outcomes. • Directed the IT Governance and Compliance team through completion of 5 projects on time and within budget, for the overarching quality management system implementation, including gathering system and functional requirements and analyzing regulatory, financial and marketing risks. Recruited to rehabilitate the testing effort, synthesizing user roles to just 10 from a pool of 7.5K users —and developing System Access SOP that effectively tested all functional areas. Delivered Register Product and Registration module implementation in just 6 months, when the normal timeframe was 12 months. Registar STAR Award—for out-of-the-box thinking and team leadership.

Designed, developed, and implemented Quality Assurance (QA) test plans, and test cases (IQ, OQ, PQ); conducted root cause analysis and developed solutions including implementing Corrective and Preventive Actions (CAPA); and ensured a smooth transition of projects into production. Led meetings and conducted workshops with business process owners, SMEs, and marketing team for requirements gathering during planning.Notable Achievements: • Key contribution to a Next Generation Complaint System (QMS) project that involved creating, evaluating and reporting complaints (IND Safety Reports, SAE Reporting) to the FDA. Reduced report generation time from 1 hour to just a few minutes by implementing interactive advanced excel reporting with significantly higher efficiency for management of issue reporting and solution development.• Tested 8K training modules across 4K courses, impacting 80K users using a highly efficient sampling method that radically reduced the total tested—that resulted in validated and stable operations• Promoted to Test Lead for Sharepoint project and led testing team in submitting status reports and executing test cases.• Closed 20 change requests in just 6 months as lead tester for PMDA (previous complaints system) project, in collaboration with IT SME, which kept the legacy system working.