SUMMARY:

• Technical Expertise - Technically astute and results-focused management professional with proven success in leadership roles in analysis of business requirements to design, support, and lead IT projects for strategic system solutions in a regulated pharmaceutical, healthcare, or biotech environment. Lifelong learner adept in ability to learn advanced technology and new concepts quickly to maximize organizational success. Managed IT projects with healthcare, biotech & Pharma experience with full SLDC in both waterfall and agile mythologies.
• Project Manager/Leadership - Experience with Pharma, biotech and healthcare software applications with IT management and deliver skills. Delivered projects on time and within budget. Strong organizational skills; works well under pressure and with minimal supervision. Ability to manage shifting priorities and demands. Ability to TEMPeffectively drive execution and own responsibility for overall success of projects. Ability to develop and follow complex communication plans, project plans and provides status report to Senior management and other organization supervisor and leaders.
• Strong analytical and creative problem-solving skills. Technical proficiency and customer-facing skills. Direct, lead, manage D&me & ERG, GXP projects, programs and portfolios in teh Pharma industry for various departments. Planning, coordinating, representing & follow ups with various vendors, teams and IT. Multifaceted leader adept in management of multiple simultaneous projects and systems improvements in teh biopharmaceutical and stem cell banking industry. Skilled in oversight of requirements analysis to develop technical design, system solutions, and website updates.
• Manage all phases of software project lifecycle with oversight of specification and requirement definition, planning, design, coding, scheduling, resource allocation, test planning, and performance testing. Manage data migration and financial projects. Managing time, scope, budgets & onsite and offshore resource, scheduling new deliver and customized enhanced pharma, healthcare and biotech systems. Managed GXP processes to deliver validation deliverables for validated environment and applications. Developing and executing SDLC deliverables.
• Manage onsite, offshore, vendor and other resource by tracking weekly status reports and identifying and managing any risks, issues and dependencies. Manage cost TEMPeffectively from end-to-end project plan across multiple responsible parties with stakeholder, business user, developer, tester validation engineer, quality control, vendors, if any third party vendor, PMO group and etc. TEMPEffectively communicating and escalating issues, roadblocks, and risks to management while maintaining responsibility for their resolution, to ensure teh successful launch of each project. Maintain validation deliverables documentations according to IT/QA/PMO standard in share locations software and standard for future audits by internal, external, FDA, states or local counties audits.
• Demonstrating thought leadership in discussions with business partners to ensure delivery of teh most TEMPeffective solutions for teh identified business objectives. Driving priorities and deadlines to completion. Coordinating multiple cross functional interactions with multiple business units stakeholder, business users, PMO, IT, vendors and internal other departments.
• Customized Applications - Lead development of application software, management of ERP systems, production planning, manufacturing, material management, system analysis, resource tracking, and delivery of high quality custom business applications.
• Regulatory Compliance - Ensure compliance with multiple regulated systems in biopharmaceutical companies requiring adherence to FDA, SOX, GXP, CSV, 21 CFR Part 11, SOP and other state and federal regulations.
• Staff Leadership & Collaboration - Skilled communicator with strong interpersonal abilities to develop rapport with internal and external customers, business and technical users, and management to provide report documentation and convey complex information in understandable terms.
• PM, BA & QA - Strong knowledge experience as PM, BA & QA. Worked in multiple phases for applications, for developing business strategies to successfully planning, requirements, validate, testing, execute projects, Writing Use Cases for various objects levels for applets, views, screens. Follow and under Strong knowledge in Software Life Cycle and Business Analysis Methodologies. Understanding and Working knowledge on QMS defect tracking tool, HP Quality Center, Selenium, Quality Manager, supply chains. Tracking multiple projects and tasks using Microsoft Project tool with expert experience in building and leveraging with multiple reports. Managing IT outsourced resources (offshore team), onsite team and vendors development, configuration, and customized software development and tasks. Working with business stakeholders, end-users, business team, requirements,
• QA and Validation teams to collect, understand, build requirements, act as a liaison between IT, data, middle-ware, sales/marketing and other departments. Support Sales & Marketing inside sales for Pharma companies. Expert in handling integration projects with multiple applications in different domain & platforms like ERP, CRM, IDMP, Financials, Labs, QMS, CTMS, HR, Facilities Management, Pharma, Aerospace and Finance. Integration involves with IT infrastructure, Vendors, Cloud-based, integrate with different applications, Databases, Middle ware and etc. Technology used are Microsoft API,
• Oracle Middle ware tools, Business intelligence tools, Unix/Linux jobs, scripts and etc. Working experience with teh CTMS tools by supporting, deployment, patches and upgrades for pharma studies in various pharma departments. Handling Master control file management systems for TMS, eTMS files & etc. Medical affairs and Drug safety pharma regulatory and submission software like CTD, eCTD, Parexel liquent, Matrix, Nees used to publish and submitted data in requested format. Implemented and decommissioned multiple environments for Development, Training, Test, Validation, Production and Disaster Recovery environments for multiple pharma software and products. Delivered QMS, Validation documentation for Validation, Production and DR products.

PROFESSIONAL EXPERIENCE:

Confidential

PM/BA

Responsibilities:

• Provide IT solution to teh HR depart from hiring till retirement process, which involves design, planning, requirements, develop, configure, test, implementation, deliver onboarding to retirement stages for teh HR systems/ technology. Enhance/maintain data quality in teh Oracle HCM and Service Now HR module. Work closely with HR and other depts and teams for business requirements. Tracked project tasks and deliverables using Microsoft Project management tool and delivered multiple reports like Gantt.
• Plan, design, requirements, validate, test cases, integrate, deploy teh iOffice application for multiple locations (USA and UK). Integrated with Service Now using API interfaces.

Confidential,Summit, NJ

IT Project PM, BA, QA & Senior Architect

Responsibilities:

• Migrate data from legacy systems into middleware and upgrade applications. Databases and applications migrations, analysis data between applications, databases and file systems/servers.
• BA/PM, admin, solution architect to lead and migrate teh ITSM from Pilgrim, handle onsite & offshore development, patches, configuration, deployment & validation deliverables. Plan and deliver enterprise solution architect design and deliverables for multiple modules in teh ITSM. Lead implementation partner, directly work with IT, halpdesk, vendor, business owners, stake holders & users for ITSM SNOW releases and patch work. Deep knowledge in ITSM SNOW multiple modules.
• To lead, test, validate, execute projects, Performing Functional Testing, Regression Testing, Integration Testing, Smoke Testing, Sanity Testing, Field Label Testing and END to END Testing. Designing and Execution of users acceptances test cases/scripts (UAT) (QMS). Develop business strategies to successfully plan and execute projects. Understand project requirements and write business documentations for project team. Assist in project design, development, testing and implementation activities. Identify business gaps and inconsistencies and accordingly develop action plans. Evaluate current business procedures and recommend improvements if needed. Assist in business risk assessment and mitigation activities. Coordinate with project team to ensure final deliverables meet customer requirements. Monitor project executions and ensure timely deliveries using teh Microsoft Project management tool for multiple projects. Medical affairs and Drug safety pharma regulatory and submission software like CTD, eCTD, Parexel liquent, Matrix, Nees used to publish and submitted data. Execute Batch jobs in Windows, Unix and Linux environments. Handling Release management, Change Management, ITIL Service Now process.
• Led multiple IT projects for multinational biopharmaceutical company with oversight of design, implementation, and release of Siebel and Linux deployments, implementation of SAS and additional tools for SAS team, plus deployment of chemical inventory tracking system. Direct and support all IT projects with customized vendor build from end-to-end with implementation and delivery using full SDLC processes and procedures. Deployed cloud-based Salesforce and Veeva for Marketing grp. Manage, lead and deployment teh LIMS Labvantage application in multiple environments for lab team to store, track and manage samples and data for automated process flow and generate reports. Followed guide lines for teh GXP, CSV, 21 CFR part 11, SDLC, QMS, SOP, supply chains and other validation process to deliver, support and post production.
• Lead, test, validate, execute projects, Performing Functional Testing, Regression Testing, Integration Testing, Smoke Testing, Sanity Testing, Field Label Testing and END to END Testing. Designing and Execution of Test Cases. Develop business strategies to successfully plan and execute projects. Understand project requirements and write business documentations for project team. Assist in project design, development, testing and implementation activities. Identify business gaps and inconsistencies and accordingly develop action plans. Evaluate current business procedures and recommend improvements if needed. Assist in business risk assessment and mitigation activities. Coordinate with project team to ensure final deliverables meet customer requirements. Monitor project executions and ensure timely deliveries.
• Veeva Vaul t system administrator for teh day-to-day administration. Worked with teh vendor for any major issues/bugs in teh application. Coordinate with teh vendor for Veeva product releases. Configuration change requests on lifecycles, workflows, security settings, objects, document types/subtypes, etc. Understand teh integrations well and work with teh support teams for any issues. Monitor alerts and troubleshoot critical production issues impacting end-users, including system unavailability and data integrity issues. Work directly with teh support teams to bring open halp desk issues to a resolution by triage and monitoring progress. Assist with internal and external audits including compliance. Provide training support for teh brand teams and other home office business units in teh development, communication and training of Veeva Vault changes. Oversee and participate, as needed, in User Acceptance Testing. Implement policy directives and instructions to manage information through its life cycle. Provide support to developers during regular code releases. Lead teh yearly SOP review and updates. Create and update standard compliance reports and alert brands of upcoming content expiration monthly.
• Teh SalesLogix CRM was migrated to teh Salesforce CRM includes database, forms, reports and interfaces. Teh migration initiative was handled with vendor, offshore and onsite teams for teh Confidential Cellular Therapeutics CCT LifebankUSA / LifebankUSA.com.
• Spearheaded LifebankUSA website and integration projects dat required website hosting with an outside vendor, monitoring project control for business team, oversight of integration and implementation of SalesLogix, StemLab, Solomon, and website site deployment.
• Oracle, SQL, PL/SQL, Forms, Reports, Pro*C, SQL Loader, Oracle Database, Oracle Designer, Matrix, Blueprint, IRise, ServiceNow, ITSM reporting, IDMP, MODA, HP ALM, Concerto, DTP, Subversion, Reference Manager, AWS/Cloud, Veeva, SalesForce, SAS, Jreview, Reference Manager, Reviewplease, InForm, Central Designer & Coding, Medidata RAVE, IRT, RBM, PACE, Pinnacle 21, QMS, EQMS, LIMS, CTMS/Clinical Product Study, SIEBEL, Facilities/Chemical Tracking System, CRM, ERP, LAB systems, Clinical DW/OBIEE, Sharepoint, Publishing Systems Trackwise, CTD, eCTD, Parexel, Nees, Clinical and Safety Dataware systems, OBIEE, BigData & etc.
• Others software includes but are not limited to InForm, Central Designer & Coding, Medidata RAVE, IRT, RBM, PACE, Pinnacle 21.

Reporting Tools- BI tools Qlik, Tableau, Teradata, SAS BI, Oracle BI & Microstrategy.

Confidential, Cedar Knolls, NJ

IT Project Leader / Senior Architect

Responsibilities:

• Website Management - Managed design, updates, and support of company website. Collaborated with multiple departments to upgrade site and integrate other applications to optimize efficiency.
• IT Systems - TEMPEffectively led IT systems administration and support at teh facility.
• Compliance - Ensured compliance with all CCT standards, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements.
• Technology - Java, J2EE Cutting Edge Technology, Hibernate, Springs, Struts, Servlets, XML, SalesLogix Solomon, StemLab, IDMP and LIMS. Oracle, SQL, PL/SQL, Forms, Reports, Pro*C, SQL Loader, Oracle Database, Oracle Designer.

Confidential, Summit, NJ

IT Consultant

Responsibilities:

• IT Projects - Managed design and implementation of an order management system (COMS OP), reports system (CRS), integration of finance business codes in teh C4 system, plus software source control system, and Req-Pro systems.
• Project Support - Provided technical support for all systems and applications and collaborated with multiple departments, teh Sharp distribution vendor, and teh Solomon customer care center. Track project tasks and multiple roles and responsible using MS project tool as a project deliverables.
• Compliance – Ensured compliance with all CCT standards, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements for teh biopharmaceutical industries. Managed documentation and validation of documents.