Senior Manager, Manufacturing IT Manager & Digital Operations

About Us

Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.

With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.

At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential.

The Manufacturing IT Manager is responsible for overseeing all manufacturing and shop-floor IT systems within a GMP-regulated pharmaceutical environment. This role ensures uptime, compliance, and integration across Production, Packaging, Serialization, Quality, Engineering, Supply Chain, Labs, and EHS. The leader will support machine-level operations, drive digital transformation, and ensure strict adherence to GxP and data integrity requirements. This role will be responsible for IT systems across all ANI Pharmaceuticals manufacturing sites across Minnesota, Wisconsin, and New Jersey.

• Own and evolve a portfolio of critical manufacturing systems — MES, ERP integrations, LIMS, QMS, data historians, SCADA/DCS — ensuring they are stable, validated, and business-enabling.
• Provide hands-on line support for production and packaging equipment: HMIs, scanners, printers, weigh scales, robotics, vision systems, batch controllers, and line integration technology.
• Drive real-time troubleshooting on the production floor; build escalation frameworks that get issues resolved fast and root causes documented properly.
• Serve as the accountable IT owner for all manufacturing system change control, vendor management, and lifecycle planning.

• Lead IT oversight for end-to-end serialization across all packaging lines — from equipment configuration through regulatory submission.
• Manage Level 2–4 serialization systems (Antares, Systech, Tracelink, Optel) and ensure seamless integration with ERP, Quality, and regulatory data flows.
• Own DSCSA, EU FMD, and global serialization compliance — partnering closely with Quality and Supply Chain to maintain audit readiness and full traceability at all times.
• Proactively identify serialization risks; communicate them clearly to leadership and mobilize cross-functional response before they become audit findings.

• Set and sustain the standard for GMP, cGMP, and GAMP 5 compliance across all manufacturing and lab systems — this is a non-negotiable foundation, not a checkbox.
• Lead Computer System Validation (CSV) end-to-end: URS, FS, DS, IQ/OQ/PQ, periodic reviews, and change control — building capability in the team to reduce cycle time without compromising quality.
• Uphold ALCOA+ principles for data integrity and electronic records; maintain readiness for 21 CFR Part 11, Annex 11, and applicable QC/QA processes across all sites.
• Act as a trusted voice in Quality forums — capable of explaining technical risk in plain language and proposing pragmatic, compliant solutions.

• Operate as the primary IT executive partner for Production, Packaging, Quality, QC Labs, Warehouse, Engineering, Maintenance, EHS, and Supply Chain — building relationships grounded in trust, transparency, and delivery.
• Lead business engagement forums, prioritization councils, and change control boards — facilitating alignment across functions with competing priorities and timelines.
• Translate operational pain points into digital roadmaps and executable programs of work; communicate progress, risks, and decisions in a way that resonates with both plant-floor supervisors and the C-suite.
• Proactively surface cross-functional dependencies, resolve conflicts early, and…