Senior Manager, Manufacturing IT Manager & Digital Operations
ANI Pharmaceuticals, Inc.
August 20, 2026
Remote friendly (Princeton, NJ)
United States
IT
About The Role
- Oversee manufacturing and shop-floor IT systems in a GMP-regulated environment across Production, Packaging, Serialization, Quality, Engineering, Supply Chain, Labs, and EHS. Ensure uptime, compliance, integration, and adherence to GxP and data integrity.
Responsibilities
- Own/evolve manufacturing systems and integrations (MES, ERP, LIMS, QMS, data historians, SCADA/DCS); ensure they are stable and validated.
- Provide hands-on support for HMI/scanners/printers/weigh scales/robotics/vision/batch controllers and line integration.
- Lead real-time troubleshooting; create escalation frameworks and document root causes.
- Accountable IT owner for manufacturing system change control and lifecycle planning.
- Lead end-to-end serialization oversight (equipment configuration through regulatory submission); manage Level 2–4 serialization systems (Antares, Systech, Tracelink, Optel) and integrations.
- Own DSCSA/EU FMD/global serialization compliance for audit readiness and traceability.
- Set standards for GMP/cGMP/GAMP 5; lead end-to-end CSV (URS, FS, DS, IQ/OQ/PQ, reviews, change control).
- Uphold ALCOA+ data integrity; support Quality forums and communicate technical risk.
- Lead cross-functional prioritization, roadmaps, change control boards, and inspection/audit representation.
- Drive Pharma 4.0 (paperless batch records, digital logbooks, automated reporting, IoT, AI) and system upgrades/migrations/integrations.
- Manage vendor relationships, contracts, SLAs, and performance reviews.
- Oversee OT infrastructure and cybersecurity; ensure OT/IT segmentation and align with corporate patching/backup/DR/access governance.
- Provide 24/7 on-call support; incident response, RCA, corrective actions, and closure.
- Lead/develop OT and automation IT teams; succession planning.
Skills/Competencies
- Strong technical leadership with disciplined, data-driven problem solving.
Qualifications / Requirements
- Bachelor’s in IT, Supply Chain, Regulatory Affairs, or Manufacturing Engineering (advanced degree a plus).
- 10+ years in pharmaceutical serialization (Tracelink or EPCIS-based systems).
- 4+ years leading cross-functional programs/teams.
- Deep expertise in MES, ERP (SAP preferred), LIMS, QMS, SCADA/DCS, and serialization integration.
- Hands-on CSV experience (GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+) and multi-site audit compliance.
- Travel up to 30% between MN, NJ, and WI.
Compensation & Benefits
- Base salary range: $150,000–$175,000; eligible for STI/LTI incentive program (if applicable).
- Health, life/disability, retirement savings, paid leave/holidays, and paid time off (subsidized/fully paid by company).
- Oversee manufacturing and shop-floor IT systems in a GMP-regulated environment across Production, Packaging, Serialization, Quality, Engineering, Supply Chain, Labs, and EHS. Ensure uptime, compliance, integration, and adherence to GxP and data integrity.
Responsibilities
- Own/evolve manufacturing systems and integrations (MES, ERP, LIMS, QMS, data historians, SCADA/DCS); ensure they are stable and validated.
- Provide hands-on support for HMI/scanners/printers/weigh scales/robotics/vision/batch controllers and line integration.
- Lead real-time troubleshooting; create escalation frameworks and document root causes.
- Accountable IT owner for manufacturing system change control and lifecycle planning.
- Lead end-to-end serialization oversight (equipment configuration through regulatory submission); manage Level 2–4 serialization systems (Antares, Systech, Tracelink, Optel) and integrations.
- Own DSCSA/EU FMD/global serialization compliance for audit readiness and traceability.
- Set standards for GMP/cGMP/GAMP 5; lead end-to-end CSV (URS, FS, DS, IQ/OQ/PQ, reviews, change control).
- Uphold ALCOA+ data integrity; support Quality forums and communicate technical risk.
- Lead cross-functional prioritization, roadmaps, change control boards, and inspection/audit representation.
- Drive Pharma 4.0 (paperless batch records, digital logbooks, automated reporting, IoT, AI) and system upgrades/migrations/integrations.
- Manage vendor relationships, contracts, SLAs, and performance reviews.
- Oversee OT infrastructure and cybersecurity; ensure OT/IT segmentation and align with corporate patching/backup/DR/access governance.
- Provide 24/7 on-call support; incident response, RCA, corrective actions, and closure.
- Lead/develop OT and automation IT teams; succession planning.
Skills/Competencies
- Strong technical leadership with disciplined, data-driven problem solving.
Qualifications / Requirements
- Bachelor’s in IT, Supply Chain, Regulatory Affairs, or Manufacturing Engineering (advanced degree a plus).
- 10+ years in pharmaceutical serialization (Tracelink or EPCIS-based systems).
- 4+ years leading cross-functional programs/teams.
- Deep expertise in MES, ERP (SAP preferred), LIMS, QMS, SCADA/DCS, and serialization integration.
- Hands-on CSV experience (GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+) and multi-site audit compliance.
- Travel up to 30% between MN, NJ, and WI.
Compensation & Benefits
- Base salary range: $150,000–$175,000; eligible for STI/LTI incentive program (if applicable).
- Health, life/disability, retirement savings, paid leave/holidays, and paid time off (subsidized/fully paid by company).