Lead Engineer, IT Compliance, Data Integrity

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary
The Lead Engineer, IT Compliance, Data Integrity is an individual contributor within the Cell Therapy Information Technology organization supporting Bristol Myers Squibb's Bothell, WA manufacturing site. This position applies technical expertise to support the compliance, integrity, validation, and continuous improvement of GxP computerized systems while contributing to organizational learning, technology adoption, workforce capability development, and digital transformation initiatives. The role collaborates closely with IT, Quality, Manufacturing, Engineering, Supply Chain, and Validation teams to execute compliance activities, support organizational change, evaluate learning effectiveness, and use data-driven insights to improve business performance and regulatory compliance. This position contributes to cross-functional projects and shares subject matter expertise with colleagues, supporting operational excellence and employee development within a highly regulated pharmaceutical manufacturing environment without direct people-management responsibilities.

Key Responsibilities

• Lead IT compliance and data integrity programs supporting GxP computerized systems used in Cell Therapy manufacturing, quality, laboratory, and business operations.
• Facilitate and oversee Data Integrity Risk Assessments (DIRAs), Quality Risk Assessments (QRAs), system impact assessments, and compliance evaluations.
• Lead complex investigations, root cause analyses, deviation management activities, CAPA development, and effectiveness monitoring using structured problem-solving methodologies.
• Support computerized system validation activities throughout the system lifecycle, including risk assessments, validation strategies, protocol reviews, implementation support, and periodic reviews.
• Conduct compliance assessments and change impact evaluations for system upgrades, enhancements, infrastructure changes, and digital transformation initiatives.
• Lead internal audits, self-inspections, data integrity assessments, and regulatory inspection readiness activities while ensuring timely remediation of findings.
• Develop and implement training strategies, competency frameworks, and learning programs that support compliance, technology adoption, and workforce development.
• Design and evaluate instructional materials, learning pathways, job aids, and digital training solutions to improve employee performance and operational effectiveness.
• Partner with stakeholders to drive technology-enabled learning initiatives, including the use of AI, automation, and digital solutions that enhance user experience and compliance outcomes.
• Apply change management principles to support organizational readiness, stakeholder engagement, user adoption, and sustainable implementation of new technologies and business processes.
• Facilitate workshops and cross-functional teams focused on innovation, continuous improvement, and design-thinking approaches to solve complex business and compliance challenges.
• Conduct applied research and quantitative analysis to evaluate learning effectiveness, organizational performance, compliance trends, technology adoption, and process improvement opportunities.
• Develop performance metrics, dashboards, and data-driven recommendations to support strategic decision-making and resource planning.
• Mentor team members and provide leadership in the areas of compliance, organizational learning, human performance improvement, and digital transformation.

Specific Knowledge, Skills, Abilities:

· Ability to effectively communicate with both technical and non-technical team members.

· Provide leadership in defining and implementing solutions for complex, ambiguous challenges aligned with team priorities.

· May represent team or function on program or project teams. Exceptional interpersonal skills, especially regarding Teamwork and collaboration, Client focus, and Verbal and written communication

· Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.

· Experience leading or supporting:
◦ Root Cause Analysis and Investigations
◦ Quality Risk Assessments (QRA)
◦ Data Integrity Risk Assessments (DIRA)
◦ Change Control and Change Management
◦ CAPA and Deviation Management
◦ Internal Audits and Self-Inspections
◦ Computerized System Validation (CSV)
◦ Regulatory Inspection Readiness

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