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Work Background
Astellas PharmaSenior Director Quality Assurance (Market/Commercial)
Jan. 2023 - Aug. 2024Chicago, Illinois, United States
Black Diamond TherapeuticsDirector GxP Quality Systems and Compliance
Jan. 2021 - Jan. 2023Cambridge, Massachusetts, United States
Dr. Reddy's LaboratoriesDirector GxP Quality Systems
Aug. 2018 - May. 2021Princeton, New Jersey
Biopharma IndustryContractor QA GMP
Oct. 2016 - Aug. 2018New York City Area
Johnson & Johnson (McNeil Consumer Healthcare USA)Lead Quality Systems
Nov. 2010 - Oct. 2016Greater Philadelphia Area► Direct complex technical and logistical functions which includes monitoring several internal business systems which are responsible for documental control, compliance, and validation
► Analyze current business process, select automation tool, develop, maintain and train users on EDM, RCTS and EInfotree Systems to ensure compliance with quality/regulatory requirements.
► Played an integral role in the integration of EDM to compliance wire which resulted in streamlining internal training processes and improving efficiency ► Assure systems remain in a validated state and under change control to ensure alignment with current business, IT system development lifecycle methodology and regulatory requirements in addition to troubleshooting and investigating system issues
► Promoted to help lead several IT quality systems projects for Consent Decree remediation and support quality system improvement plan and standardization
► Reviewed and approved all SDLC validation documentation and ensure the systems are built in a compliant manner along with creating SDLC validation documentation as needed
► Implemented Event Management/CAPA Assessment Programs. Developed SOP’
► Provided QA review and approval support on projects as required and created a data integrity audit checklist.
► Utilize exceptional communication abilities in order to foster positive collaboration with internal users in addition to identifying expected service level requirements
Johnson & Johnson (McNeil Consumer Healthcare USA)Sr. Analyst, Quality Information Systems Technical Lead
Aug. 2008 - Nov. 2010Greater New York City Area► Accountable as a technology lead for day to day management of the internal TrackWise system implementation which required developing appropriate software business process applications, maintaining current processes, and overseeing data integration processes
► Oversaw the development and management of various systems such as events, deviations, investigations, CAPA, audit management, commitment tracking, EH&S, and change control processes. Lead integration with SAP R/3. Developed and maintained a Complaints Management system for global roll-out
► Facilitated the standardization of quality system processes with a focus on maintaining alignment with internal best practices, maintained internal budgets, supervised a cross-functional technical team during the build of a ETS-Trackwise Global system, and managed the integration of the ETS-Trackwise system into existing quality systems.
Johnson & Johnson (GPSG)Validation Lead (Consultant)
Aug. 2007 - Apr. 2008Greater New York City Area► Developed SDLC validation deliverables for a pilot trackwise implementation for a 21CFR part 11 compliant Deviation Management system and Audit Management.
► Assisted users with an event management system which included analyzing software requirements, determining business needs, and documenting of the requirements specifications for process automation and MRP(Mfg-Pro) system integration.
► Maintained a keen knowledge of the software development lifecycle which resulted in consistently meeting project deliverables and successfully planning a new system rollout
► Performed system testing in order to ensure functionality, monitored compliance, performed disaster recovery testing, and managed the change control board for the system.
► Vendor Management responsibilities to ensure agreements are in place and to ensure required functionality is built in the system
Schering-Plough (now Merck)Global Quality Information System Support: Sr. Quality Analyst
Jun. 2003 - Jun. 2007Greater New York City Area► Directed several technical and system support functions within a fast-paced environment with a focus on increasing system productivity and overall efficiency within the entire organization
► As a member of the Consent Decree Commitment Team, Supported the development and deployment of a portal for 14 Manufacturing sites by integrating disparate MRP systems for “Where Used Where Made” global queries.
► Played a lead role in the implementation of a reference standards management system used by the global quality group which included a web-based inventory enterprise manager and document manager
► Assisted in the implementation of a web-based stock keepers system, a complaints management, deviation, and CAPA management system, and an environmental monitoring LIMS system
► Assisted as a Quality Assurance reviewer and approver for some of the laboratory and spreadsheet validation systems. Conducted 21CFR part 11 audit for laboratory systems (Empower)
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