EXECUTIVE SUMMARY:

• Governance, Risk, Compliance, Quality Lead/Manager with extensive experience in Risk Management, Software Quality Assurance, System Validation, Change Control Management, Security compliance, Application Development, Infrastructure/Data Center Management, Vendor Management, Service provider management, Strategy Management, Incident/Problem Management to businesses across a variety of industries.
• Excellent track record to meet individual and team objectives, company objectives, establishing solid relationships through trust and mutual respect. Bridging business needs to the best - fit technological solutions.
• Ability and Experience in managing Agile Scrum, Waterfall projects.
• Extensive experience in supporting Global projects (EMEA, ASPAC, LATAM, CANADA).
• Excellent presentation skills delivering IT presentations, project status/project heath, project road-maps to mid to Sr. Management VP, CIO, Directors.
• Extensive experience in meeting quality and regulatory requirements such as GMP/GxP, SOX, COBIT, HIPAA, CMS, GxP/ FDA (21 CFR parts 11, 210, 211, 820) regulations.
• Well versed in GAMP 5 industry guidelines.
• Experienced in Agile and Waterfall Methodologies.
• 7 Yrs. in life sciences, Compliance and Computer System Validation (CSV).
• 3 yrs. of experience in Data Center Infrastructure validation.
• 4 yrs. of experience in System/Application Validation.
• Experience in validating ERP systems, LIMS, Clinical systems, Laboratory equipments, Plant/Site validations.
• Software Quality Assurance (SQA), Business Process Validation, Data Integration Compliance, System Validation, IT Infrastructure system verification & Qualification (IQ, OQ, PQ), FAT, SAT.
• Experience in Validating & Supporting R&D, Clinical & LIMS systems.
• Review and approval of Business Process Documentation, URS, SRS, FRS, DS, FS, TS, TM.
• Authoring and review of Compliance/Validation Plan, Compliance Report, Test Protocols, Test Summary Report.
• Extensive experience in auditing, supporting internal audits and external FDA audits. Performed review and audits related to Data Integrity.
• Review and approval of Requirements, Test Plans, Test Runs, Test Defects and resolution.
• Change Control and Change Management.
• Compliance related to SAP system enhancement, break fixes, admin changes, for multiple SAP platforms like Security, Supply Chain, Finance, Purchasing, Order management, Inventory functions & Basis Functions. Web methods system related to developing interfaces with SAP.

PROFESSIONAL EXPERIENCE

Database: Oracle, SQL Server, MS Access, SQL, PL/SQL

Programming Languages: Java, .Net, Visual Basic

MS Tools: MS Visio, Word, Excel, SharePoint

PM Tools: MS Project, JIRA, Rational Requisite Pro

PROFESSIONAL EXPERIENCE

Confidential, Waukegan, IL

Software Quality Assurance

Responsibilities:

• Leading an Initiative to build Post Merger integration approach to Implement Abbott Software Lifecycle (SLC) for Quality Systems.
• Facilitating workshops to assess GAPS and requirements for SLC phases.
• Helping teams with System Risk Classifications.
• Leading effort to build Validation methodology to bring existing systems to Validated state.
• Building approach to Mitigate risks on current Non-Validated systems.
• Go to approach on new or up-coming project initiatives.

Confidential, Skillman, NJ

Software Quality Assurance

Responsibilities:

• Providing guidance/support on multiple projects, global teams on system risk assessments or platform specific risk assessments. Determining GxP Quality and Non-GxP (Regulatory), SOX Compliance and Security Risk Assessments.
• Supporting/Guiding multiple vendor and project teams on compliance/SDLC deliverables.
• Supporting projects following Agile scrum and Waterfall methodology approach.
• Supporting project team on Quality Systems implementation for new acquisitions.
• Authoring SDLC deliverables like Compliance/Validation plans, Validation Summary Report, Test Protocols, Test Summary report, Compliance Summary Report.
• Review and approval of project based documentations like Compliance Analysis, GxP Risk Assessment, Business Impact statement, FD, TD’s, Config Doc, Code Reviews, URS, FRS, Test Plan, Test Run, defects etc.
• Executed and verified data integrity programs at functional levels and production units.
• Periodic review of Audit Trails, back-up data along with associated MetaData. Review and approval of CGMP records.
• Ensuring data integrity is maintained at all levels, records are complete, consistently maintained and accurate as per the guidelines/procedures for individual systems.
• Participating in daily scrum meetings and project specific meetings to guide teams on adherence to SDLC deliverables and following Agile/Scrum process or project management process as per company guidelines.
• Change Control Management, CR/CO reviews, participating in CAB reviews.
• Conducting external vendor audits and supporting internal and external FDA audits.
• Follow ups on SOP creation, review and approvals specific to policy guidelines related to SDLC, Agile framework, Waterfall Framework, Change Control processes.
• Assisting project teams in creation, review and approval of User Requirements Functional Requirements, Test Protocols, Test scripts, Test Run, Managing and documenting defects,
• Supporting/guiding teams on execution of qualifications IQ, OQ, PQ on COTS applications and infra applications.
• Supporting review and approval of security changes, security and access permissions to users of supply chain, finance applications.
• Review and approval of Requirements, Traceability Matrix report, Functional Design, Technical Design.
• Guiding project teams on J&J policies and guidelines and SDLC requirements for project specific needs. .
• Supporting multiple project teams with concerns/issues related to change management, compliance/system validation.

Confidential

Validation Lead

Responsibilities:

• Project scoping, planning, execution, project estimation, and testing for new server builds, Windows server upgrades to 2012.
• Gathering inventory, Hardware profile, Utilization Data, Services used.
• Creating compliance and validation documents.
• Roll out communications to various stakeholder’s, user communities, with regards to changes in File Server folder structure and new user groups permissions.
• Documenting Identity Management policies and guidelines.
• Providing guidance in the creation policies and procedure related to SOP’s/WI, IQ, OQ, PQ on newly installed systems and system and application upgrades.
• ITSM, Change process management and change control.
• COBIT, SOX Compliance.

Confidential, Lake Forest, IL

Compliance Lead, Software Quality Assurance

Responsibilities:

• Led compliance efforts on $8 million outsourced migration project, migrating prod and non-prod data centers to single location, incorporating 1200 servers (physical and Virtual), 160 applications.
• Led compliance efforts working along with 3rd party vendor teams, starting from discovery phase of the project to final migration of the project.
• Managed and coordinated efforts between third party build and migration teams, third party QA team and Service delivery teams.
• Overseen and Led third party quality schedule with project teams, to managecompliance/validation resources for different project stages and successful completion of deliverables.
• Coached project teams on adhering to SDLC and follow Quality systems procedures.
• Directed efforts among multiple technical teams/engineers and CSV teams in the creation, review and approval of Master Validation Plan, SOP’s, Hardware and Software Qualification plans, FAT, SAT testing procedures/qualification for laboratory equipment’s and facility testing.
• Documented Data Integrity procedures, computer system workflow validation, procedures related to CGMP record retention and restricted access.
• Overseen the design and implementation of new access management solutions with regards to validating the entire system and creating documented evidence at different stages/cycle of the implementation.
• Confidential global infrastructure operations team’s and business teams for issues related to connectivity to data centers and any impact on applications interfacing or integrating with multiple regions.
• Followed Hospira policies and guidelines with respect to user access and permission and granting access and permissions as per the approved guidelines.
• Evaluated and verified systems with respect to ensuring dat proper access and permissions are granted as per the pre-approved roles and designations.
• Supported authoring/creation of validation and qualification documents (IQ/OQ/PQ) for new hardware and infra applications.
• Led efforts in creation, review and approval of Data Center Design in coordination with Hospira Internal architects and Vendor Project teams.
• Led efforts in creation, review and approval of Network and Security Qualification plan for new data center in coordination with Hospira’s internal network/security team, Vendor Project Teams.
• Led efforts in authoring of Master Validation Plan and separate validation plans for different Hardware appliances, Infra Applications, master data plan and changes to existing applications validation plan.
• Closely coordinated efforts with Disaster Recovery Team.
• Provided timely insight on project performance to key stakeholders, sponsors and project teams through weekly status on project deliverables, milestone reports, various forecasts, risk analysis in a detailed and summarized form.
• Overseen and monitored the validation and compliance activities for all new systems builds and changes.
• Supervised team of validation analyst and members from project team to author validation documents.
• Directed team to evaluate and verify the procedures and guidelines with respect to GxP, Non-GxP, cGMP and SOX categories and channelizing the same with project teams.
• Confidential change management team and various SME’s to establish guidelines to manage and control changes and established CR process for Data Center build and migration.
• Established guidelines with respect to changes in Dev, QA and Prod environment.
• Communicated the change process with project teams, to properly manage changes at various stages/activities undertaken as per the project schedule.
• Monitored, reviewed and approved changes with respect to scheduled activities and contingency plan.
• Confidential cross-functional service delivery teams to support build and migration activities at various stages.
• Managed and controlled service requests for services related to back-up/storage, security, networking, monitoring and working with service delivery teams to ensure the timely delivery of services.
• Provided leadership and guidance to project team and system engineers to follow the system qualification process.
• Directed Hospira CSV/SQA team along-with project team to help coordinate the qualification efforts.
• Facilitated the creation of Qualification plan document in coordination with CSV/SQA team for qualifying systems in New Data Center build.
• Led the creation of new documentation (ITSOP’s, HQ, SQ and guidelines) for various missing to be qualified systems with the help of system engineers and worked along with Hospira SMEs and SQA team for review and pre-approval of qualification steps.
• Led effort to customize HPQC to support pre-and post-approval of qualifying systems as the new Quality Control system.

Tools Used: Remedy, Service Now, SOLMAN, Clarity, SharePoint, MS Project, Excel, Word, HPQC, CHARM

Confidential, Warrenville, IL

Compliance/Validation Lead (Computer System Validation)

Responsibilities:

• Technology services and outsourcing firm combining unparalleled experience with comprehensive capabilities in niche technologies and business functions.
• Managed/led multiple projects including technical solution, implementation, support and quality.
• Single point of escalation for customer.
• Identifying and negotiating agreements/contracts with customers.
• Presenting project proposals and project reports up to C level and weekly, bi-weekly and Monthly status on regular basis.
• Managed budgets/projects over 1m to up to 6m in range.
• Periodic project forecasting and monitoring of project cost against the baseline.
• Creating contingency plans, taking preventive and corrective actions.
• Risk management related to scope, quality, schedule, cost, contingency reserves.
• Project scheduling, estimate activity durations, task assignments, budget estimating.
• Change control and change management strategies.
• Provided guidance and support to project teams in Computer System Validation (CSV) for life sciences client.
• Involved in the process of authoring, reviewing, verifying and approving validation documents at various stages in SDLC lifecycle.
• Performed test reviews to verify and validate test results as per the tractability matrix and requirement metrics.
• Prioritize work and schedules.
• Involved with human resource planning.
• Provide direct supervision and mentoring of project teams. Provided project performance feedback to stakeholders, team members, supervisors/managers.
• Participate in the research, analysis, selection, and implementation of new tools, technologies and/or services.

Confidential, Vernon Hills, IL

Software/Clinical Systems

Responsibilities:

• Project involved Application Development to support EMR (Electronic Medical Records), third party payments, insurance, Medicare Part B, Medicaid Management
• Researched, Compiled and Documented regulatory requirements for project team to be incorporated is different requirement specifications document.
• Performed compliance and validation of applications with respect to Confidential /CMS regulatory requirements.
• Development and implementation of systems with respect to CMS regulations for tracking claim submissions, claims retrievals, claim queries and claims acnoledgement. The project involved usage of ICD 10 and 5010 release versions for EDI (X12) containing the transactions for HIPAA standards.
• IT Environment:Oracle9i, MS Excel, Agile, Oracle, UML, Rational Rose, SharePoint, Requisite Pro, MS Office Suite, XML, MS Visio 2003Project Lead
• Worked on the development and enhancement of the billing center for the Property & Casualty in an agile environment.
• Oversaw the documentation of use cases, data-mapping specifications, business process diagrams, user interface specifications, and FRS documents.
• Served as a conversion analyst for capturing requirements on the conversion of customer accounts into billing center.
• Confidential the development team to create technical solutions and documentation.
• IT Environment: Microsoft Visio, Rational Requisite Pro, SharePoint, SQL, Agile

Revenue Cycle Management RCM Application

Confidential, Chicago, IL

Responsibilities:

• The project was to develop a cloud-based ERP system by defining business processes for hospital business units from patient in-take to billing.
• Project Planning, create project Schedule, maintained project status.
• Coordinated day to day development efforts between client and offshore team to ensure business rules and requirements were clearly communicated.
• Helped development and client teams in providing clarifications by daily scrum calls for clearing any backlogs, burn down chart, and change requests.
• The client was a global E-commerce business, an education company dat provided innovative and proprietary products, programs and services to help educators engage and inspire students of all ages and abilities. Through leading brands, School Specialty designed, developed and provided Prek-12 educators with the least and very best curriculum, supplemental learning resources, and classroom basics. Working in collaboration with educators, School Specialty reached beyond the scope of textbooks to help teachers, and guidance counselors ensure dat every student reached his or her full potential.
• Worked on understanding the current state of existing site and documented (UI elements and descriptions), the required changes for future state.
• Worked on high level requirements into functional business requirements for development resources (white boarding, user focus groups, conceptualization, and design).
• Worked closely with major skate-holders, business users to formalize a business idea and define requirements.
• Conducted JAD and brain storming sessions with business users and stakeholders.
• Conducted meetings with all the division supervisors to ensure dat all the requirements were met.
• Implemented the approved suggestions and modified the current process flows.
• Implemented the concepts and requirements for B2B and B2C users in design docs.
• Worked closely with different 3rd party vendors to gather information and coordinated required information from them.
• Worked on mapping content and recognized the type of content to be gathered and worked on initial draft to create folios in Oracle Web Center.
• Gathered noledge in Search Engine Optimization (SEO), OCM, UCM, and GSA procedures for the web positioning.
• Confidential Development and QA teams to transition business requirements into QA test cases and assisted in UAT.
• IT Environment: ACE, WIKI, EBS, Vision, Greenshot, Axure
• Worked as an independent insurance advisor/producer to help facilitate client needs for different insurance requirements.
• Worked on customer requirements in Confidential, life, auto and commercial lines of products.
• Helped clients identify the right policy and guided them various policy features.
• Worked and helped clients on settling claims.
• Confidential multiple insurance companies and multiple insurance products to help find right insurance coverage for customers.

Confidential

Vendor Management

Responsibilities:

• Leading provider of IT consulting services with expertise in enterprise and mobile technologies through a global setting.
• Clients: Cisco, Sanmina, Oracle, Microsoft etc.
• Supported various client engagements as project coordinator, focusing on monitoring and controlling of various projects per the project timelines.
• Managed coordination resource allocation among different project teams depending on the criticality, availability and project timelines.
• Worked closely with the project teams to manage deliverables.
• Managed relationships with multiple vendors.
• Contract negotiations, agreements with Vendors and clients.
• Managed status reports on the deliverables on weekly and bi-weekly basis and circulated them among the project teams.
• Facilitated conference calls between IT managers, business functions and offshore team.
• Sorted escalations from clients on various issues, by addressing those in timely manner and coordinating/communicating between different project groups.
• Helped coordinate client interviews of candidates to be assigned on projects.
• Supported clients identifying job requirements and helped clients with writing job descriptions and identifying the skill set required.
• Helped coordinate transition of candidates from offshore to onsite and vice a versa.
• Helped manage cost by identifying and getting candidates from offshore and involved in their visa process.
• Partnered with business leaders to align resourcing strategy with business growth, and led acquisition of candidates from India.
• Negotiated contracts with clients, vendors and consultants.
• Closely coordinated efforts with HR on onboarding of candidates, their orientations and assign them on projects.
• Helped resolve candidate’s issues in different areas of HR.