CAREER SUMMARY:

• Twenty years of diverse experience in Quality leadership, Compliance Management, Laboratory Information Management System, Software Engineering, Information Technology Management, Remediation, Project Management, and Quality Control. Possess expertise as a Compliance Leader and regulatory environment by involving in developing/reviewing documentation for SDLC, Computer Systems Validation with profound knowledge of Confidential 21 CFR Part 11, GxP environment, Validation Practices for Medical devices, and Verification and Validation. Hold Strong Analytical, Design, Remediation, Development, Managerial, Documentation, Maintenance, Issue Resolution and Change Control procedures expertise.
• Pioneered new and better ways to implement for trials for development, investigators and patients or GxP Environment
• Worked as Sr. Validation/Quality Engineer, Validation Manager, Quality Director/Manager, Compliance Manager and Global Lead and enforced Confidential rules and regulations & helped to respond consent decrees
• Managed remediation projects
• Implemented many LIMS projects - especially Labware LIMS
• Developed and implemented GDPR/Data Privacy and Integrity policies
• Oversaw many CMOs (contract manufacturers) for process characterizations and process development
• Authored many manuals and SOPs for user community after successfully deploying new releases or projects
• Improved and streamline systems to improve flexibility, usability and data quality
• Managed multiple high-level projects for government, pharmaceuticals, biotech and Financial industry
• Simplified processes and decision-making structures
• Enhanced and embed insights and data analytics capabilities to support decision making, productiveness and operational efficiency
• Determined what work needs to get done and how much to invest in which efforts and how to prioritize opportunities
• Worked as IT compliance Manager and developed many IT governing policies
• Provided on the QMS subjects of Design Control, Risk Management, Design Change Control, Validation and Quality Engineering
• Set strategic imperatives or mandates and establish KPI to track proficiency and effectiveness
• Worked on various Regulatory Information Systems (RIM)
• Taught Business Analysis, Quality Assurance, Data communications and PMP courses for graduate level students
• Involved in PMO processes - developing project documents - project plan, status reports, facilitating project meetings, proactively reaching out to various groups for closing out issues and connecting the dots between business & IT shared services and took part in cost and efforts estimation
• Comprehensively assessed options and analytical strategies and identified team needs and recommends solutions
• Expert with industry standard methodologies like Agile, SCRUM, XP, Rational Unified Process (RUP), Waterfall and industry specific Hybrid models.
• Facilitated, supported and motivated team members

SOFTWARE:

Operating System: Windows & UNIX, Linux

RDBMS: Mainframe, DB2, MS SQL Server, Oracle, and MS-Access

Testing Suite: Mercury Quality Center, QTP, Load Runner and Rational Suite

Web Tools: MS Visio, Rational Rose, Rational Requisite Pro, Rational Clear Quest, and DOORS

Project Management: MS Project, Team Track, MS Excel, MS office Suite, JIRA, Version 1, Service Now, MS SharePoint etc.

Programming Languages: HTML, XML, Java, SQL, JavaScript,, SAS, C

Other applications: Blueworkslive, eRoom, Documentum, Filenet, Content Management, StarLims, Rational Rose, Test Manager, UML, SPSS, EDMS, Track Wise, Documentum, NuGenesis, Empower, Varitas, Argus, Oracle Clinical, LIMS, Labware LIMS, RIM, CAPA, Matlab, MINitab, QMS, QSR,MES, SAP, ICIS, Xybion, Blue Print, Blueworks Live, ALM, and reporting tools etc.

Expertise: Project Management, Quality System Requirements, Quality Systems, Management, ISO Standards, Compliance Management, Quality Control and Management, Medical Device Directive, FDA- 21cfr, Code of federal regulations part 11-electronic records and electronic signatures, Good manufacturing practices (GMP), Life Cycle testing, Quality Assurance & Compliance Management, Six Sigma, Good Laboratories Practices (GLP), Good Clinical Practices (GCP), Good Automated Manufacturing Practice (GAMP), LIMS, GDPR, Remediation, functional specs, Test planning and Test management, Application development, and Defect investigation and reporting

PROFESSIONAL EXPERIENCE:

Sr. Project Manager /Sr. Validation Engineer

Confidential, Framingham, MS

Responsibilities:

• Responsible for Labware V 7 implementation
• Responsible for enforcing data integrity and privacy (GDPR)
• Developed Master Validation plan
• Developing Data Migration plan
• Uploading material specifications into the system
• Building Master Data
• Leading the team to create configuration specifications
• Providing guidance for testing and UAT scripts
• Reviewing the process and documentation
• Evaluating global risks to mitigate them because it is global deployment
• Providing guidance to business and system owners regarding validation and compliance
• Converting the legacy system into automated system

Global Validation Manager (IT Risk and Compliance Manager)

Confidential, Cordova, TN

Responsibilities:

• Reviewed the process and documentation
• Implemented GDPR policies after developing it
• Improved and streamline systems to improve flexibility, usability and data quality
• Enhanced and imbedded insights and data analytics capabilities to support decision making, productiveness and operational efficiency
• Facilitated, supported and motivated team members
• Used in house RIM for cross verification and compliance purpose
• Evaluated existing artifacts and processes
• Oversaw external and internal audits
• Empowered compliance by mitigating risks
• Enforcing Confidential, European and Canadian rules and regulations for Medical Device Industry
• Evaluated global risks to mitigate them
• Provided guidance to business and system owners regarding validation and compliance

Project Manager/Scrum Master

Confidential, Vienna, VA

Responsibilities:

• Involved in PMO processes - developing project documents - project plan, status reports, facilitating project meetings, proactively reaching out to various groups for closing out issues and connecting the dots between business & IT shared services and took part in cost and efforts estimation
• Modified budgets as necessary when the scope changed
• Managed a highly sophisticated application regarding Credit Reporting Management Systems using Agile methodology
• Designed embedded application having multiple integrations
• Worked also as Scrum Master apart from being manager
• Implemented cloud-based approach and adding extra layers of firewalls for cyber security due to having highly sensitive private information in mortgage applications
• Enforced all QA and compliance rules and regulations related to financial industry

Sr. Validation Lead

Confidential, Boston, MA

Responsibilities:

• Enforced Confidential rules and regulation
• Over saw IT compliance transformation
• Worked as primary CSV engineer
• Audited CMOs
• Managed multiple projects and corresponding deployments
• Implemented new LMS (learning management system)
• Worked on enhancements project of Labware V6
• Developed Master Data Migration Plan and conducted migration
• Worked to establish GIS (GxP) system within company
• Implemented SAS for quality management purpose
• Reviewed and approved new releases
• Approved validation documents

Compliance Director/Sr. Validation lead/Sr. Quality Director

Confidential, Fairfax, VA

Responsibilities:

• Managed many different projects related Confidential rules and regulations having multiple roles
• Managed IT transformation based on industry best practices
• Developed scope of projects and budgets
• Managed and approved change control and configuration procedures
• Worked for many CROs and ran trials
• Developed and implemented GDPR
• Involved also in the analysis, design, configuration, integration and maintenance of LIMS systems and interfaces with other corporate enterprise systems ECM, ELN, CDS, QAD, and Master Control
• Responsible for Drug substance and Drug product validation efforts
• Improved and streamline systems to improve flexibility, usability and data quality
• Enhanced and embed insights and data analytics capabilities to support decision making, productiveness and operational efficiency
• Implemented Labware LIMS for multiple clients
• Developed Master Validation plan
• Created Material Specifications and uploaded
• Created Configuration Specifications
• Developed Data Migration plan
• Build Master Data from the scratch
• Led the team to create configuration specifications
• Facilitated, supported and motivated team members
• Worked as investigator and taking Corrective and Preventive action (CAPA)
• Developed IT Governance policies
• Developed validation plans, risk assessments, prototypes, protocols, summary reports and key personnel index
• Worked on Risk assessment and system upgrade
• Validated templates, procedures and all policies against GxP environment
• Set strategic imperatives or mandates and establish KPI to track proficiency and effectiveness

Director

Confidential, Falls Church, VA

Responsibilities:

• Involved in PMO processes - developing project documents - project plan, status reports, facilitating project meetings, proactively reaching out to various groups for closing out issues and connecting the dots between business & IT shared services and took part in cost and efforts estimation
• Responsible for managing budgets and resources
• Pioneered new and better ways to implement for online course development, materials development and catalog development
• Managed, Designed and developed online portal for university
• Managed knowledge Department as well implemented online
• Also taught PMP, business analysis and data communications course.
• Transferred technologies from legacy systems to automated systems and deployed it

Sr. CSV Manager/ Global Lead

Confidential, Elmira, NY

Responsibilities:

• Helped respond consent decree
• Managed large scale remediation project
• Worked as Validation project and program manager with coordination 17 global teams
• Maintained the final deliverables; keeping content current and establish effective version control and quality controls throughout their development
• Implemented Confidential rules and regulations, GAMP5 and ISO quality management process and putting out of scope systems into Quarantine environment

Sr. Software Quality Engineer/Lead Engineer

Confidential, Ann Arbor, MI

Responsibilities:

• Helped respond consent decree for Confidential
• Acted as Lead Quality Engineer in Quality Control department
• Implemented device systems for SDLC in accordance with Confidential requirements and IEC62304
• Reviewed and developed system to track master records
• Applied Quality tools, including Quality Management, US QSR, ISO 13485, ISO 14971, DFMEA, PFMEA, GR&R/measurement system analysis, control plans, process verification/validation plans
• Authored and updated many SOPs (standard Operating procedures) as necessary
• Validated templates, procedures and all policies against GxP environments
• Put out of scope systems into Quarantine environment
• Recommended appropriate CA/PA as requirement

Project Manager/Sr. Business Analyst

Confidential, Washington, DC

Responsibilities:

• Involved in PMO processes - developing project documents - project plan, status reports, facilitating project meetings, proactively reaching out to various groups for closing out issues and connecting the dots between business & IT shared services and took part in cost and efforts estimation
• Worked integration project and helped implement SAP
• Planed and managed schedules; tracked key activities outputs, schedules, managed issues; performed risk mitigation and manage deliverable quality Supported in development and implementation of quality management plan
• Designed, developed and implemented new Calendar management systems based on legacy systems

IT compliance Manager/ Sr. Quality Engineer

Confidential, Washington, DC

Responsibilities:

• Developed IT Governance policies.
• Conducted case study for IVD
• Implemented device systems for SDLC in accordance with Confidential requirements and IEC62304
• Reviewed and developed system to track master records
• Facilitated compliance and system audits
• Tracked implementation plan, issues, report and all other project activities daily.
• Developed over all IT policies based on the industry standards and best practices.
• Analyzed system and document audits.
• Performed GAP Analysis
• Worked on Risk assessment
• Performed system and documents audits
• Implemented ISO and Confidential rules and regulations
• Validated templates, procedures and all policies against GxP environment

Project Manager/Sr. Business Analyst

Confidential, Washington, DC

Responsibilities:

• Involved in PMO processes - developing project documents - project plan, status reports, allocations of budgets, facilitating project meetings, proactively reaching out to various groups for closing out issues and connecting the dots between business & IT shared services and took part in cost and efforts estimation
• Worked as project manager in the Employment Benefit Services
• Planed and managed schedules; tracked key activities outputs, schedules, managed issues; performed risk mitigation and manage deliverable quality Supported in development and implementation of quality management plan
• Managed and approved change control and configuration procedures
• Coordinated with project team to create and release Product Software Requirements, Design Specifications and Design Descriptions
• Elicited TO BE requirements based on AS IS requirements
• Converted the legacy unemployment benefit distribution system into state of art automatic system