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 · Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices. · Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing. · Exceptional technical and problem-solving skills and the ability to work independently. · Demonstrated success working in a high-performing, business results-driven environment. · Understanding of computer system validation and SDLC methodologies.
Education/Experience/ Licenses/Certifications:
· Bachelor's degree in Information Technology, Chemical, Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, Education, Organizational Development, Business Administration, or a related field. · Must have experience with IT Compliance applications and systems in a bio-tech manufacturing environment. · Must have 5+ years of hands-on experience in a biotech manufacturing and supply chain environment. · Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems, Process Automation and Historians. · Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
Preferred:
· Master's degree or Doctoral degree in Education, Organizational Leadership, Learning & Development, Business Administration, Engineering, Information Technology, Pharmaceutical Sciences, or related discipline. · Current enrollment in or completion of a Doctor of Education (EdD), Organizational Leadership, Learning Sciences, or related doctoral program. · Experience designing and delivering organizational learning, training, curriculum development, leadership development, or workforce capability programs. · Experience applying adult learning principles, instructional design methodologies, and performance improvement frameworks. · Experience conducting quantitative research, program evaluations, data analysis, or applied organizational research. · Experience leading digital transformation initiatives, technology adoption programs, or AI-enabled learning solutions. · Experience with Manufacturing Execution Systems (MES), eQMS platforms, ServiceNow, SAP, Oracle, Agile/JIRA, laboratory systems, or electronic batch record systems. Experience within Cell Therapy, Gene Therapy, Biologics manufacturing environments.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
Bothell - WA - US: $118,280 - $143,325
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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R1608102 : Lead Engineer, IT Compliance, Data Integrity