Senior Manager, Manufacturing IT Manager & Digital Operations

Senior Manager, Manufacturing IT Manager & Digital Operations

Princeton, NJ, United States (Hybrid)

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, offering accessible products across a wide range of therapeutic areas to support communities globally. At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day.

We value authenticity, knowledge, and hard work, and our culture empowers every employee to succeed and apply their full potential in a positive environment.

About the Role

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 spans all ANI Pharmaceuticals manufacturing sites across Minnesota, Wisconsin, and New Jersey.

Responsibilities

1. Manufacturing Systems & Shop-Floor Technology

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 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.

Proactively identify serialization risks; communicate them clearly to leadership and mobilize cross‑functional response before they become audit findings.

3. GMP Compliance, CSV & Data Integrity

Set and sustain the standard for GMP, cGMP, and GAMP 5 compliance across all manufacturing and lab systems.

Lead Computer System Validation (CSV) end‑to‑end: URS, FS, DS, IQ/OQ/PQ, periodic reviews, and change control, reducing cycle time without compromising quality.

Uphold ALCOA+ principles for data integrity and electronic records, maintaining inspection readiness across all sites.

Act as a trusted voice in Quality forums, capable of explaining technical risk in plain language and proposing pragmatic, compliant solutions.

4. Cross‑Functional Leadership & Stakeholder Partnership

Operate as the primary IT executive partner across all manufacturing functions, 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 for both plant‑floor supervisors and the C‑suite.

Proactively surface cross‑functional dependencies, resolve conflicts early, and ensure no critical initiative stalls because stakeholders aren’t aligned.

Represent IT in regulatory inspections, customer audits, and internal quality reviews.

Drive Pharma 4.0 initiatives: paperless batch records, digital logbooks, automated reporting, IoT sensors, machine connectivity, and AI‑based intelligence…