Quality/CSV Validation Lead with 16+ Years Experience

HARINA SRINIVASA

Raleigh, NC US Citizen ***************@*****.***

QUALITY / CSV / GMP VALIDATION LEAD

SUMMARY

Quality and Computer Systems Validation professional with 16+ years of progressive experience across pharmaceutical, biotech, healthcare, financial services, and technology domains. Extensive hands-on expertise in CSV/CSA, equipment onboarding, SOP authoring, Change Control, CAPA, IQ/OQ/PQ execution, QMS governance, and vendor qualification. Proven Quality Lead partnering with Manufacturing, QA, Engineering, and IT to deliver compliant systems on aggressive timelines while driving continuous improvement through risk-based validation and quality metrics.

CORE COMPETENCIES

CSV / CSA • GMP / GxP Compliance • Equipment & System Qualification • SOP Authoring • Change Control • CAPA • IQ/OQ/PQ • Vendor Management • Risk Assessments (FMEA) • QMS • SiMD, UAT • Agile Delivery • Power BI / Tableau • ServiceNow • Jira • SAP • Oracle • TrackWise • Kneat

Regulatory/Compliance: ISO,2022 NIST, FDA,21 CFR, HIPAA, GMP, LIMS, Sox, cGMPs, FDA, EU, ICH, ISO, GAMP, EudraLex, MES, Delta-V, PI data historianand CAPA.

PROFESSIONAL EXPERIENCE

CELLECTIS – Global Computer Systems Validation Specialist Raleigh, NC July 2024–Present

• Lead site-wide CSV/CSA activities for GMP-regulated platforms including LIMS, ELN, ERP, LMS, CRM, MES, Kneat, EMS, and cloud environments.

• Author Validation Master Plans, IQ/OQ/PQ protocols, SOPs, URS/FRS/DS/CS documentation, and validation summary reports.

• Support equipment onboarding and qualification in collaboration with QA, Manufacturing, Engineering, and IT.

• Manage Change Controls, deviations, and CAPA support while proactively escalating compliance risks.

• Serve as Quality Lead in project meetings, providing technical guidance on validation strategy and regulatory expectations.

• Conduct FMEA risk assessments, vendor qualification audits, and system lifecycle management.

• Deliver validation metrics and compliance dashboards to stakeholders.

• Support upgrades, configuration changes, rollback testing, and edge hardware validation while maintaining QMS and GMP alignment.

TOSHIBA GLOBAL COMMERCE – Senior QA Engineer Durham, NC Dec 2022 – June 2024

• Validated POS hardware, firmware, and software deployments across retail environments.

• Supported test environment setup, equipment procurement, edge device provisioning, and network configuration.

• Executed regression, integration, system, and UAT testing supporting controlled releases.

• Authored validation documentation, test plans, and traceability matrices.

• Participated in remediation submissions, change management, and risk assessments.

• Collaborated with product and engineering teams to resolve compliance issues.

CREDIT SUISSE – Quality Assurance Analyst April 2022 – September 2022

• Led QA governance for SOX-regulated Swift ISO20022 migrations.

• Managed Change Controls, risk management, defect triage, and UAT signoffs.

• Coordinated cross-functional testing activities and stakeholder communications.

• Produced quality dashboards and compliance reporting for leadership.

BELL & HOWELL – QA Automation Engineer Sept 2021–March 2022

• Qualified OEM hardware/software solutions and cloud systems.

• Managed incident tickets, SLAs, and change management workflows.

• Executed functional, integration, regression, and performance validation.

• Developed automation suites and validation reports supporting system readiness.

GK SOFTWARE – Senior QA Engineer Jan 2021-Jul 2021

• Validated POS, pharmacy, and omnichannel systems, including hardware integrations.

• Led UAT, regression, and integration testing.

• Managed Change Requests, Incident Management, and defect triage.

• Supported customer onboarding, patch upgrades, and compliance testing.

BB&T / Truist – Sr.QA NC December 2019 – May 202

• Implemented validation plans for enterprise cyber and regulatory systems.

• Performed compliance gap analysis, remediation planning, and audit evidence collection.

• Coordinated QA activities, including BCA, UAT, and penetration testing.

• Supported SOX, ISO, and NIST regulatory readiness.

DELOITTE – QA Manager Oct 2015–Jun2019

• Acted as Quality Lead for healthcare regulatory platforms and digital transformation initiatives.

• Managed validation strategy, SOP alignment, UAT, releases, and change controls.

• Delivered PMO quality metrics, risk registers, and compliance reporting.

• Led offshore/onshore QA teams and facilitated Agile ceremonies.

RIVERBED TECHNOLOGY – Lead QA Oct 2013–Sept 2015

• Led E2E system qualification, UAT signoffs, defect management, and release validation.

• Authored SOPs, validation artifacts, and operational documentation.

• Supported CRM, ERP, and cloud platforms.

• Managed Change Controls, remediation activities, and SLA governance.

INTEL – Quality Assurance Analyst May 2013-Oct 2013

• Validated POS hardware/software systems and business workflows.

• Led UAT execution and metrics reporting.

• Authored operational procedures and acceptance documentation.

NETAPP – QA / Defect Manager Nov 2011–April 2013

• Managed production defect lifecycle and validation activities for ERP/CRM platforms.

• Coordinated UAT, data migrations, and release approvals.

• Developed risk management frameworks and change management processes.

BLUE SHIELD – QA Lead May2010–April 2011

• Led validation of healthcare CRM and Medicaid systems.

• Executed batch data verification, UAT, and regulatory documentation.

• Supported CMS certification readiness.

INFOED GLOBAL – Lead Performance & Regression Engineer Feb2007–March2010

• Led validation of clinical trials and research administration platforms.

• Managed STLC lifecycle, patch certifications, and production releases.

• Developed performance testing frameworks and compliance documentation.

• Delivered executive dashboards and quality metrics.

EARLY CAREER

• Supported CT, ultrasound, Lab equipment upgrades, validation protocols, and clinical workflows, SiMD for GE & Konica.

EDUCATION & CERTIFICATIONS

MS in Science – VMU, India

Medical Devices Certification – UC Berkeley / Laney College

PMP CSM SQA ITIL ITSM

TOOLS

Power BI, Tableau, ServiceNow, Jira, SAP, Oracle, SQL, TrackWise, Kneat, SharePoint, MS Office

Revalent Experience:

Styker- Orthomedic- SiMD.

InfoEd Internaltional Experience

Cellectis Biopharmaceutical.

FDA 820 CFRs/ISO 13485/cGMP,GxP, Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian) quality management system

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