Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Major Accomplishments
Timeline
Generic

Bijal Shah

Piscataway

Summary

Dynamic IT leader with extensive experience at Bristol Myers Squibb, specializing in computer system validation and regulatory compliance. Demonstrated success in strategic planning and project management, fostering cross-functional collaboration and optimizing resource allocation. Committed to driving process improvements and mentoring teams to deliver exceptional outcomes in high-stakes environments.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Associate Director, IT Strategy & Operations

Bristol Myers Squibb
Berkley Heights
08.2023 - 02.2025
  • Led the Computer System Validation (CSV) initiatives for enterprise-wide IT systems, ensuring compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11), and internal quality standards.
  • Collaborated with IT delivery teams, business stakeholders, and Global Quality compliance staff to define validation strategies, execute risk-based validation activities, and maintain adherence to SDLC and agile frameworks.
  • Introduced an automated tool for Resource Capacity Management to elevate IT Quality Services scalability
  • Introduced RAID log for proactive issue management and ensuring project success by documenting and addressing potential problems early on
  • Instituted a library of SharePoint sites for collective team utilization, simplifying access, visibility, data sharing, and single source project alignments
  • Mentored junior level professionals, committing time to excellence, morale building, and skill development to elevate quality workflows
  • Designed and deployed a standardized Demand Intake form for IT Quality Services, now widely adopted across IT to streamline the request process for validation
  • Served as the subject matter expert in IT risk assessments, compliance validation for core IT projects, coordinate financial reporting requirements, and apply agile governance
  • Align with cross functional teams (IT, Business and Finance, to optimize an annual $4M+ operating budget
  • Oversee regulatory benchmarks, cost efficiency practices, and GxP applications
  • Employed a new model for optimizing workload management for greater visibility into departmental contributions
  • Consolidated the on-site consultant workforce to pave the way for more budgetary flexibility and improved project coordination
  • Assisted senior leadership team in developing long-term strategic plans for the organization.
  • Held regular one-on-one meetings with employees to review performance and priorities and provide feedback.
  • Implemented innovative solutions for difficult problems encountered by the department.
  • Introduced a cross-learning process, expanding knowledge access to 30+ validation experts outside of their functions (R&D, ERP, Commercial, etc.), improving efficiency and teamwork
  • Coordinated with other departments to ensure successful completion of projects within established timelines and budgets.
  • Collaborated with finance department to manage budget and forecast expenses.
  • Introduced a Resource Capacity Model that optimized operational budgeting dynamically over availability

Senior Manager, Health Authority Inspection & Strategy Lead

Bristol Myers Squibb
05.2020 - 08.2023
  • Played a vital multi-disciplinary role to align and develop coordinated processes for cross-functional validation processes in IT, Health Authority Compliance, and quality assurance.
  • These included oversight of validation requirements, quality control management, technical process design, and business unit management.
  • Opened the door for the creation of KPI metrics for the T2 IT Quality Council to improve processes and engagements.
  • Curated a visualized project progress dashboard, synergizing goals, contributions, and global IT project communication flows.
  • Compiled accurate records of data for external inspections by the FDA, MHRA, SwissMedic, and global auditors.
  • Integrated the Regulatory Risk Assessment into the CI creation process, streamlining operations, and eliminating manual effort.
  • Connected domestic and global teams (IT, Business, and QA) to ensure a systematic verification process, procedural quality, and analytical alignments for a fail-proof validation service process.
  • Led a multi-faceted governance process for cross-functional team development to ensure collective process oversight, to exceed specified quality standards, and to deliver intended outcomes.
  • Proactively managed the internal and external audits, inspections, and regulatory reviews to assure project validations, focusing on data governance, role accountability, compliance, and GxP.
  • Ensured that project teams have sufficient resources to successfully execute CSV projects by providing appropriate staffing, comprehensive training, and access to essential tools and technologies.
  • Served as the lead author for budget allocation, project timeline management, delivery of outcomes, and systems maintenance to assure compliance, completion, and quality execution on IT validation objectives.
  • Tasked with leading the health authority inspection management process for IT operations and enterprise data systems, I developed highly impactful workflows, data governance standards, and cross-functional communication objectives.
  • Aligned goals with ITQA teams to conduct self-audits, classify documentation, and develop a system of good practices across IT.
  • Oversaw the Corrective and Preventive Action (CAPA) management for IT functions and enterprise computer system findings and observations identified during health authority inspections.
  • Provided IT leadership with status updates on health authority inspections, including inspection activities, findings, observations, and CAPAs related to IT functions and enterprise computer systems.
  • Provided strategic direction to departmental heads regarding resource allocation decisions.
  • Created detailed reports on project progress for senior management review.

IT Release/Change Management Lead

Celgene
01.2015 - 05.2020
  • Led the Release & Change Management Processes by overseeing the end-to-end release and change lifecycle, ensuring alignment with ITIL best practices and organizational goals
  • Triaged the Review Request for Change (RFC) with the development team .
  • Authored User Acceptance Test (UAT) scripts for ServiceNow enhancements
  • Provided training and guidance on the use of new tools or systems related to changes.
  • Facilitated workshops and meetings to discuss proposed changes and their impacts.
  • Planned & coordinated software releases, collaborating with development, testing and operations teams to ensure timely and successful deployments
  • Assessed, prioritized, and approved CRs to minimize risks and prevent service disruptions
  • Identified and implemented process enhancements to streamline change and release activities, improving efficiency and reducing incidents
  • Ensured adherence to compliance standards and generated regular reports to track KPIs and audit readiness

Education

B.S. - Business Management

New Jersey Institute of Technology
NJ

Skills

  • Computer system validation
  • Regulatory compliance
  • Risk assessment
  • Project management
  • Stakeholder engagement
  • Budget management
  • Change management
  • Cross-functional collaboration
  • Resources allocation
  • Strategic planning
  • Team collaboration and leadership
  • Process improvement

Certification

GAMP 5 Training

Accomplishments

- Led Celgene & Juno and Celgene & BMS M&A IT Changeover
- Introduced CAB Workbench

- Supported 50+ HA Inspections
- Led the BMS Hyderabad ITQS Team
- Implemented ITQS Capacity / Demand Management Model

Major Accomplishments

  • Led Celgene & Juno and Celgene & BMS M&A IT Changeover
  • Introduced CAB Workbench
  • Supported 50+ HA Inspections
  • Created gap analysis to reduce spend
  • Created cross learning skills for teams
  • Led the BMS Hyderabad ITQS Team
  • Implemented ITQS Capacity / Demand Management Model

Timeline

Associate Director, IT Strategy & Operations

Bristol Myers Squibb
08.2023 - 02.2025

Senior Manager, Health Authority Inspection & Strategy Lead

Bristol Myers Squibb
05.2020 - 08.2023

IT Release/Change Management Lead

Celgene
01.2015 - 05.2020

B.S. - Business Management

New Jersey Institute of Technology

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