Lead Engineer, IT Quality and Compliance

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Key Responsibilities: Own site‑level quality oversight for Manufacturing and Laboratory IT systems, including support for deviations, investigations, and CAPAs, ensuring sustained compliance and inspection readiness. Accountable for IT Change Management governance, providing risk‑based oversight and acting as the primary site authority for IT change control. Act as a Validation Lead for Manufacturing IT and OT systems, accountable for approval and lifecycle compliance of CSV and SDLC deliverables. Maintain ongoing compliance accountability for IT systems, procedures, and training supporting CAR‑T manufacturing and laboratory operations. Lead the Site IT System Periodic Monitoring program, ensuring effective execution, documentation, and remediation of compliance risks. Provide data integrity governance and strategic guidance, identifying systemic risks and driving continuous improvement initiatives. Serve as the primary liaison with the Summit site training team to own the Manufacturing and Laboratory IT Training Program, ensuring role‑based curricula, training effectiveness, and sustained inspection readiness. Support Manufacturing and Laboratory IT Quality during Health Authority inspections and audits, including preparation, direct support, and post‑inspection remediation. Provide cross‑functional leadership and mentorship, partnering with Site IT organizations and guiding consulting staff to ensure compliant delivery and operational readiness. Qualifications: Education/Experience/ Licenses/Certifications: Bachelor's degree required. Degree in a STEM discipline is preferred. Must have experience with IT Quality & 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. 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. 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. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Madison - Giralda - NJ - US: $107,530 - $130,295 Summit West - NJ - US: $107,530 - $130,295 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. ​Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, f