Manager II - IT Compliance Lead
Core
Ensures IT systems and solutions at the Boudry manufacturing site comply with GMP, 21-CFR Part 11, and EU-GMP Annex 11 through risk-based oversight, validation, and continuous monitoring.
Role type
Manager II, IT Compliance Lead (Pharmaceutical Manufacturing)
Builds
Compliant IT infrastructure and computerized systems for BMS manufacturing operations
Domain
Pharmaceutical manufacturing / Life Sciences / IT Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), GxP compliance, Data Integrity, Risk Management, Regulatory Standards (21-CFR Part 11, EudraLex, MHRA), IT Infrastructure, Process Improvement
Preferred skills
MES/LIMS knowledge, Cross-functional collaboration, Strategic planning, Mentoring
Technologies
Operating Systems, Networking, Systems, MES, LIMS
Responsibilities
Oversee strategy for Infrastructure qualification and GxP computerized systems lifecycle; Facilitate cross-functional collaboration and lead meetings on IT topics; Analyze data to identify gaps and recommend compliance solutions; Support deviation assessments and investigations; Manage local IT documentation alignment; Provide training and mentorship; Lead process or system improvement projects.
Seniority
Manager II, hands-on IC with strategic oversight
