Quality Assurance Product Owner

CAREER SUMMARY

Results-driven professional with extensive experience in Computer System Validation (CSV), Quality Assurance, CQV, Data Integrity, and Business Analysis. Adept at managing enterprise system validation, regulatory compliance, and cross-functional collaboration. Proven ability to optimize processes, lead teams, and drive successful project execution. Certified Scrum Product Owner (CSPO) with expertise in GxP compliance, system decommissioning, and validation lifecycle management.

Data Management Business Development Customer Relationship Management Computer System/ Equipment Validation 21CFR11/ ICH Q9/ Annex 11 Guidelines ISO 9001

Quality System Management Full Project Life Cycle Management Document Review Operational Support GMP Regulations Organizational Skills Regulatory Compliance Leadership & Initiative Effective Communication Data Integrity Implementation Time Management

• Led data archival projects that reduced storage costs by $1M+ annually.

• Spearheaded system validation optimizations, cutting project execution time by 30%

• Improved compliance readiness, reducing regulatory audit findings by 20%, mitigating potential penalties and non-compliance risks.

• Automated system decommissioning, saving $1M+ in IT infrastructure costs.

• Implemented risk-based validation approaches, reducing validation effort by 25% MODERNA Norwood, MA

CSV QA SPECIALIST, GLOBAL QUALITY COMPLIANCE (09/2022 to Present)

• Led validation efforts for GxP enterprise systems (Chromeleon, Hamilton, LIMS, LabX, Spectramax) and automation integration (Scitara).

• Ensured compliance with regulatory guidelines (21 CFR Part 11, Annex 11), reducing audit findings by 40%.

• Streamlined validation documentation processes, reducing validation cycle time by 25%

• Provided QA oversight for manufacturing and laboratory system implementation, enhancing operational efficiency.

NEHUL SHAH

14 Maymont Dr, Framingham, MA 01701 732.66.89475 **********@*****.*** https://www.linked.com/in/shahnehul/ CORE QUALIFICATIONS

KEY ACHIEVEMENTS

PROFESSIONAL EXPERIENCE

TAKEDA Lexington, MA

SR. CSV ENGINEER / CQV (09/2021 to 09/2022)

• Led software upgrade projects for Ellab, Osmometer, and NC-View Cell Counter, ensuring compliance with 21 CFR Part 11.

• Optimized risk-based validation strategies, cutting project execution costs by $150K.

• Developed and executed IQ, OQ, and PQ protocols, reducing system downtime by 20% and improving productivity.

• Enhanced IT and QA collaboration, reducing JIRA ticket resolution time by 30%. BIOGEN RTP, NC

PROJECT MANAGER / BUSINESS ANALYST (03/2019 to 09/2021)

• Led Enterprise Archival Solutions, reducing IT storage costs by $1M+ annually through automated record retention.

• Managed GMP system upgrades, reducing compliance gaps.

• Streamlined validation processes, improving deployment efficiency by 30%

• Ensured alignment of IT systems with evolving business needs, increasing productivity by 15% across departments.

CSV/IT VALIDATION (06/2016 to 03/2019), APPLICATION SUPPORT (03/2013 to 06/2016)

• Provided application support as an SME for pharmaceutical and lab systems (TrackWise, Empower, Discoverant, Delta V, PI, SC Logics).

• Maintained validated state for GxP systems, reducing audit deficiencies by 20% and ensuring compliance readiness.

• Authored validation protocols, reports, and SOPs, reducing documentation errors by 25% and improving process efficiency.

• Implemented TrackWise version update for improved business process automation.

• Improved documentation as a Business Analyst and implemented enhancements for the system on regular basis for system improvement and accommodating Business needs. Certified Scrum Product Owner (CSPO), Scrum Alliance 2021 MBA, Information Technology, Wilmington, DE 2015

M.S. in Chemistry & Biochemistry, University of Oklahoma, Norman, OK 2011 M.S. in Pharmaceutical Sciences, Northeastern University, Boston, MA 2009 EDUCATION & CERTIFICATION

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