Lead Engineer, IT Quality and Compliance
Bristol Myers Squibb
June 24, 2026
On-site
Summit, NJ
IT
Key Responsibilities
- Own site-level quality oversight for Manufacturing and Laboratory IT systems, including deviations, investigations, and CAPAs to sustain compliance and inspection readiness.
- Provide risk-based IT Change Management governance and act as the primary site authority for IT change control.
- Serve as Validation Lead for Manufacturing IT/OT systems; ensure CSV and SDLC deliverable approval and lifecycle compliance.
- Maintain compliance accountability for IT systems, procedures, and training supporting CAR-T manufacturing and laboratory operations.
- Lead Site IT System Periodic Monitoring; execute, document, and remediate compliance risks.
- Provide data integrity governance and drive continuous improvement.
- Own Manufacturing and Laboratory IT Training Program with role-based curricula and training effectiveness.
- Support Health Authority inspections/audits and complete post-inspection remediation.
- Lead/mentor cross-functionally with Site IT organizations and consulting staff.
Qualifications
- Bachelor’s degree required (STEM preferred).
- IT Quality & Compliance systems experience in biotech manufacturing.
- 5+ years hands-on biotech manufacturing and supply chain experience.
- Knowledge of supply chain/manufacturing tech (ERP, Process Automation, Historians).
- Knowledge of cGMP/GXP/GAMP/SDLC; 21 CFR Part 11; good documentation practices.
Skills/Abilities
- Communicate effectively with technical/non-technical teams; lead complex solutions; independent problem-solving; knowledge of Quality/Compliance methodology and computer system validation/SDLC.
Benefits (as stated)
- Health coverage; wellbeing support; 401(k) and insurance/disability benefits.
Compensation
- $107,530–$130,295 (NJ: Madison-Giralda and Summit West).
Application
- Apply even if you don’t perfectly match your resume.
- Own site-level quality oversight for Manufacturing and Laboratory IT systems, including deviations, investigations, and CAPAs to sustain compliance and inspection readiness.
- Provide risk-based IT Change Management governance and act as the primary site authority for IT change control.
- Serve as Validation Lead for Manufacturing IT/OT systems; ensure CSV and SDLC deliverable approval and lifecycle compliance.
- Maintain compliance accountability for IT systems, procedures, and training supporting CAR-T manufacturing and laboratory operations.
- Lead Site IT System Periodic Monitoring; execute, document, and remediate compliance risks.
- Provide data integrity governance and drive continuous improvement.
- Own Manufacturing and Laboratory IT Training Program with role-based curricula and training effectiveness.
- Support Health Authority inspections/audits and complete post-inspection remediation.
- Lead/mentor cross-functionally with Site IT organizations and consulting staff.
Qualifications
- Bachelor’s degree required (STEM preferred).
- IT Quality & Compliance systems experience in biotech manufacturing.
- 5+ years hands-on biotech manufacturing and supply chain experience.
- Knowledge of supply chain/manufacturing tech (ERP, Process Automation, Historians).
- Knowledge of cGMP/GXP/GAMP/SDLC; 21 CFR Part 11; good documentation practices.
Skills/Abilities
- Communicate effectively with technical/non-technical teams; lead complex solutions; independent problem-solving; knowledge of Quality/Compliance methodology and computer system validation/SDLC.
Benefits (as stated)
- Health coverage; wellbeing support; 401(k) and insurance/disability benefits.
Compensation
- $107,530–$130,295 (NJ: Madison-Giralda and Summit West).
Application
- Apply even if you don’t perfectly match your resume.