Lead Engineer, IT Quality and Compliance
Core
Own site-level quality oversight for Manufacturing and Laboratory IT systems, ensuring compliance, inspection readiness, and data integrity for CAR-T manufacturing and lab operations.
Role type
Senior IC IT Quality and Compliance Engineer
Builds
Compliant IT/OT systems and validation deliverables for biopharmaceutical manufacturing
Domain
Biopharmaceutical manufacturing / IT Quality & Compliance
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
IT Quality & Compliance applications, cGMP/GXP/GAMP/21CFR Part 11, SDLC/CSV methodologies, Manufacturing ERP systems, Process Automation, Historians, Data Integrity governance, Change Management governance, Periodic Monitoring, Training program ownership, Health Authority inspection support
Preferred skills
STEM degree, Supply chain domain knowledge, Pharmaceutical manufacturing systems knowledge, Cross-functional leadership
Technologies
Manufacturing ERP, Process Automation, Historians, IT Quality & Compliance applications
Responsibilities
Own site-level quality oversight for Manufacturing and Laboratory IT systems; Accountable for IT Change Management governance; Act as Validation Lead for Manufacturing IT and OT systems; Maintain ongoing compliance accountability for IT systems; Lead the Site IT System Periodic Monitoring program; Provide data integrity governance and strategic guidance; Serve as primary liaison for Manufacturing and Laboratory IT Training Program; Support Health Authority inspections and audits; Provide cross-functional leadership and mentorship
Seniority
Senior, hands-on IC