SUMMARY

• Governance, Risk, Compliance, Quality Lead/Manager wif 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 wif SAP.

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 wif 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 wif 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 wif 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, wif 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 wif 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 wif project teams, to manage compliance/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 Confidential ’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 wif regards to validating the entire system and creating documented evidence at different stages/cycle of the implementation.
• Worked wif global infrastructure operations team’s and business teams for issues related to connectivity to data centers and any impact on applications interfacing or integrating wif multiple regions.
• Followed Confidential policies and guidelines wif respect to user access and permission and granting access and permissions as per the approved guidelines.
• Evaluated and verified systems wif 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 wif Confidential 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 wif Confidential ’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 wif 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 wif respect to GxP, Non-GxP, cGMP and SOX categories and channelizing the same wif project teams.
• Worked wif 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 wif respect to changes in Dev, QA and Prod environment.
• Communicated the change process wif project teams, to properly manage changes at various stages/activities undertaken as per the project schedule.
• Monitored, reviewed and approved changes wif respect to scheduled activities and contingency plan.
• Worked wif 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 wif 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 Confidential CSV/SQA team along-wif project team to help coordinate the qualification efforts.
• Facilitated the creation of Qualification plan document in coordination wif 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 wif the help of system engineers and worked along wif Confidential 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.

Confidential, Warrenville, IL

Compliance/Validation Lead

Responsibilities:

• Technology services and outsourcing firm combining unparalleled experience wif 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 wif 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 wif 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

Compliance/Validation Lead

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 wif respect to Healthcare/CMS regulatory requirements.
• Development and implementation of systems wif 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 2003

Confidential, Stone River, MA

Project Lead

Responsibilities:

• Leading insurance Software Development Company. Their suite of products spanned the entire property & Casualty (P/C) insurance lifecycle, underwriting, policy administration, billing, claims, and reinsurance management.
• 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.
• Worked wif the development team to create technical solutions and documentation.
• IT Environment: Microsoft Visio, Rational Requisite Pro, SharePoint, SQL, Agile