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.

• 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 21
  
  CFR part 11, and good documentation practices.

• 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 21
  
  CFR 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.

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.

• 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…