• Support the data integrity risk assessment and remediation project at customer sites. • Evaluate the system configuration settings, access level controls, and audit trail review for instruments and equipment.• Work with QC, Digital, and QA to update the System Administration SOPs and Operation/Maintenance for DI remediation and audit trail review.• Participate in validation activities in conjunction with IT, Validation, and QA related to implementation and ongoing support for new and existing Chemistry, Biological, and Bioassay instruments.• Assist in evaluating product enhancements and capabilities, implementing upgrades as required.• Coordinate and Manage CSV and CSA activities.• Familiar with Computer Systems and Instruments Software such as Veeva, Kneat, Empower 3, Chromeleon, MODA, LabX, LogiLab SDMS, LabVantage, Maximo, iStudy, Seven Excellence, DataPro 2, and Tiamo, etc. • Complete the Client's training for applicable technical subject matter and Qualification/Commissioning to adapt the client’s QMS system and approach.• Review and approve Trace Matrix, Design Review, Verification Strategy, Test Cases, and summary reports. • Manage Change Control and deviation where applicable• Co-facilitate or participate in system Pre-startup Safety Review (PSSR)• Lead/coordinate field activities including calibration, energization, system turnover (TC), and final transfer of care to end user.• Troubleshoot field-related matters where applicable including hardware/software problems.

Director, CMO Quality 2018-2023• Responsible for the end-to-end quality management, direction, and coordination of all technical quality functions and Quality Management Systems of the site and Contract Manufacturers. Oversee and manage Quality Assurance, Quality Control Labs, and Warehouse management ensuring that all processes are compliant with regulations. Direct interaction with the FDA regarding audits, field alerts, and other circumstances as required. Direct interaction with Contract Manufacturers on quality matters such as Quality Agreements, Change Controls, Investigations, Technical Transfer, Product Release and Audits. Quality point person for the New Product Launch process from R&D development through commercialization. A close working partnership with Commercial, Supply Chain, Manufacturing, Packaging, Regulatory and R&D.Associate Director, GxP Lab Quality and Compliance SME 2016-2018• Responsible for the oversight of QC Lab data integrity in the India plant site to establish a robust Data Integrity program. Contribute facility/equipment/utility remediation project to meet the gaps identified against FDA 483s. Remediate the injectable fill line to transfer the product from the US.

• Provided project management support for the regulatory affairs CMC on new and post-marketed products. Identified potential compliance risks by comparing historical filing from eCTDs | eDOCs against current ICH requirements and manufacturing process development. Developed strategy plans and communicated them with project teams and management through Launch Excellence and SharePoint. o Prepared and/or reviewed summary tables of data from research and manufacturing reports to comply with CMC guidance for INDs | NDAs | BALs, amendments & supplements, and responses to regulatory agency questions. o Strategically composited responses to questions from FDA, EMEA, Switzerland, Canada, and Japan for HCV NDAs into a searchable database to enable speedy global filing and future INDs/NDAs.o Reviewed and updated HIV drug substance sections in eCTDs to cut multiple filing costs.o Developed strategies with management guidance to organize and prepare the drug master file (DMF/CEP) for HIV drug substances.o Interacted with international marketing and local QA staff to define the most appropriate regulatory strategies to prepare 2nd packaging site change for HIV products. o Prepared the biological application license (BAL) renewal for Adalimumab in the United Arab Emirates and the biological product filing changes in different countries using the Lots Restriction Management System (LRMS). Transferred Reference Standards testing technology into QC labs.o Consolidated Reference Standards Testing Lab into QC labs for cost-saving.

Managed analytical chemistry testing laboratory daily operation to comply with cGMP requirements. Provided lab support for over 400 reference standards characterization and requalification. Conducted laboratory investigations under CAPA. Directed analytical project teams for methods development and validation. Interfaced with regulatory/customer auditors. o Created the laboratory Validation Master Planning to capture the Commissioning, Qualification, and Validation (CQV) activities with quarterly updating for lab instruments/equipment. o Participated in IT systems development such as Empower, Thermo LIMS, Cognos, iStudy, Maximo, Records Import Management Tool, GQMS (CAPA), and SolTrags (CAPA). o Participated in drafting responses to auditing observations and deficiency letters. Established a fully equipped Analytical Reference Standards Testing Laboratory.o Directed analytical project teams for methods development and validation for an antibiotic product. o Managed analytical testing (HPLC, GC, IR, KF, titration) on over 400 different chemicals. Conducted laboratory and non-conformity investigations in a CAPA system.o Set up a control document system for Reference Standard testing protocols. o Established and characterized reference standards for new biological and chemical products.o Authored and reviewed the reference standard sections for NDAs and annual report filing.o Evaluated compendia (USP|EP) methods, specifications, and reference standards. Proposed conclusion and recommendation to compendia organizations for final action.o Authored and revised standard operating procedures (SOPs) to ensure compliance with the latest developments of ICH|FDA guidelines.o Possessed hands-on experience with analytical tests (HPLC, GC, TLC, IR, UV, TGA/DSC, Titration, LOD/KF, ROI/Residual Solvents). o Represented the Reference Standards Program, and interfaced with FDA/EMA auditors on inspections, which resulted in no significant observations over 17 years.