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Senior Manager, Manufacturing IT Manager & Digital Operations

ANI Pharmaceuticals, Inc.
August 20, 2026
Full-time
Remote friendly (Princeton, NJ)
Worldwide
IT
Role: Manufacturing IT Manager overseeing shop-floor IT systems within a GMP-regulated pharmaceutical environment, driving digital transformation, ensuring compliance, and supporting manufacturing operations across multiple sites. Responsibilities: manage critical manufacturing systems (MES, ERP, LIMS, QMS, serialization), provide hands-on support for production equipment, lead serialization compliance (DSCSA, EU FMD), uphold GMP and data integrity standards through CSV and ALCOA+ practices, drive continuous improvement initiatives, oversee OT infrastructure and cybersecurity, and support incident management. Lead and develop regional IT teams, fostering a culture of compliance and innovation. Requirements: Bachelor's in IT, Supply Chain, or Manufacturing Engineering; 10+ years in pharma serialization and shop-floor IT systems; 4+ years in leadership roles managing cross-functional teams; deep expertise in MES, ERP (SAP preferred), serialization platforms, GxP validation, and regulatory compliance (21 CFR Part 11, GAMP 5). Preferred: advanced degree, extensive GMP validation credentials, experience with Pharma 4.0 initiatives. High-Value: GMP-regulated pharma manufacturing, serialization compliance, digital transformation, GxP validation, and cross-site management. WorkSetup: regional travel up to 30% across Minnesota, New Jersey, Wisconsin.