Lead Engineer, IT Quality and Compliance

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

• 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.

Benefits

• 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