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Lupin Pharmaceuticals · 7 hours ago

Sr. Manager, IT

Somerset, NJ

Full-time

Onsite

Senior Level, Lead/Staff

$139K/yr - $165K/yr

15+ years exp

Lupin Pharmaceuticals is a fast-growing company focused on manufacturing and research in the pharmaceutical industry. The Senior Manager - IT will lead the technology ecosystem at the site, ensuring seamless integration of IT infrastructure, end-user services, and regulatory compliance while driving innovation and operational excellence.

BiotechnologyPharmaceuticalRobotics

H1B Sponsor Likely

Responsibilities

Collaborate with the DC Ops and Global IT leaders to architect and deploy scalable on-premises, hybrid, and cloud-based infrastructure (e.g., AWS, Azure) to support business growth, including servers, storage, networking, and virtualization (VMware/Hyper-V/ Nutanix)

Monitor infrastructure performance of IT & OT environments using tools like Nagios or SolarWinds; conduct root cause analysis for outages and implement preventive measures

Conduct risk assessments and implement measures to protect sensitive data and IT / OT systems against cyber threats, collaborating closely with Global IT and vendors

Enforce cybersecurity policies and ensure compliance with ISO 27001, NIST, or SOC 2 standards

Ensure IT / OT segregation

Develop, test, and maintain disaster recovery and business continuity plans for IT & OT infra

Partner with business teams, internal IT and external vendors to deliver, enhance, and support OT solutions

Oversee installation, configuration, operation, and ongoing maintenance of OT networks, automation systems, and control equipment across R&D and Manufacturing environments

Ensure compliance with GxP, FDA, and other international regulatory standards for computerized and automated OT systems

Create and maintain processes and SOPs for GMP activities including access management, data backups and system configuration controls

Ensure robust documentation, change control, and audit readiness for all OT systems & processes

Coordinate and lead remediation of system non-conformities and inspection readiness

Lead Site IT to resolve users issues & needs, providing hands-on support if needed for hardware, software, network and security

Define and monitor SLAs for incident resolution, ensuring timely responses to high-priority tickets (e.g., system outages, security breaches)

Oversee asset provisioning and software compliance of all IT devices and systems

Lead CSV activities for GxP systems, including requirements gathering, risk assessments (GAMP 5), protocol development (IQ/OQ/PQ), and traceability matrices

Ensure adherence to 21 CFR Part 11, EU Annex 11, GDPR, and HIPAA through periodic audits, validation reviews, and documentation updates

Liaise with users and global application support teams / vendors to provide application support

Collaborate with business units to optimize application workflows and reduce friction in daily operations

Develop annual IT budgets, track expenditure, and identify cost-saving opportunities (e.g., cloud cost optimization, license consolidation)

Recruit, mentor, and evaluate IT staff (e.g., Systems Engineers, Support Specialists); foster a culture of continuous learning through certifications and workshops

Define a 3–5-year IT strategy, incorporating emerging trends (AI, IoT, automation) to drive innovation and competitive advantage

Report KPIs (system uptime, incident resolution rates) to executives and translate technical concepts for non-technical audiences

Qualification

IT Infrastructure ManagementRegulatory ComplianceComputer System ValidationApplication SupportInformation SecurityPharma IT StandardsOT Systems KnowledgeLeadershipProblem-SolvingCommunication

Required

Bachelor's degree in computer science, Information Technology, or related field

15+ years of progressive IT experience, including 5+ years in lead roles in regulated industries (pharma, med devices etc.)

Proven track record in managing IT / OT, CSV, and application support for global or multi-site organizations

Strong knowledge of network infra, server admin, endpoint devices, enterprise apps

Proficiency in information security – IT / OT (familiarity with ISO 27001, NIST, SOC 2, Privacy standards)

Deep expertise on pharma IT standards, system qualification/validation (GAMP lifecycle, 21 CFR Part 11)

Hands on experience in managing devices, monitoring systems, handling incidents, deploying updates

Understanding of OT systems including lab equipment integration (HPLC, SCADA, etc.), network connectivity, backups, retrieval etc

In-depth understanding of GMP, GCP, GLP, and 21 CFR Part 11 requirements for electronic records and signatures

Experience preparing for and responding to regulatory audits (FDA, EMA, ISO)

Ability to inspire teams, manage conflict, and drive accountability in high-pressure environments

Analytical mindset for troubleshooting complex technical and compliance challenges

Good verbal & written skills for collaborating with technical teams, executives, external partners

Preferred

Master's degree or MBA

Company

Lupin Pharmaceuticals

Lupin Pharmaceuticals is a generic pharmaceutical company.

Founded in 2003

Baltimore, Maryland, USA

501-1000 employees

http://www.lupinpharmaceuticals.com

H1B Sponsorship

Lupin Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (6)

2023 (2)

2022 (8)

2021 (6)

2020 (4)