Sr. Manager, IT

Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.The Senior Manager - IT will serve as the strategic and operational leader of the site’s technology ecosystem, ensuring seamless integration of infrastructure, end-user services, application support, and regulatory compliance. The ideal candidate will balance technical expertise, regulatory knowledge, and leadership to align IT operations with organizational goals while fostering innovation and user satisfaction.This role is ideal for a forward-thinking leader who can navigate the complexities of regulated environments while driving innovation, operational excellence, and user-centric IT services. The Sr. IT Manager will ensure technology remains a strategic enabler for business success.CORE RESPONSIBILITIESIT Infrastructure ManagementDesign & Implementation: 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).System Optimization: monitor infrastructure performance of IT & OT environments using tools like Nagios or SolarWinds; conduct root cause analysis for outages and implement preventive measures.Security & Compliance: 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.Disaster Recovery: Develop, test, and maintain disaster recovery and business continuity plans for IT & OT infra.OT Infrastructure managementDesign & Implementation: 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.Compliance: 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.Audit support / inspection readiness: Ensure robust documentation, change control, and audit readiness for all OT systems & processes. Coordinate and lead remediation of system non-conformities and inspection readiness.End-User SupportService Desk: Lead Site IT to resolve users issues & needs, providing hands-on support if needed for hardware, software, network and security. Supervise and co-ordinate with Global IT and other individuals as needed.Service Level Management: Define and monitor SLAs for incident resolution, ensuring timely responses to high-priority tickets (e.g., system outages, security breaches).Asset Management: Oversee asset provisioning and software compliance of all IT devices and systems.Computer System Validation (CSV)Validation Lifecycle: Lead CSV activities for GxP systems, including requirements gathering, risk assessments (GAMP 5), protocol development (IQ/OQ/PQ), and traceability matrices.Regulatory Compliance: Ensure adherence to 21 CFR Part 11, EU Annex 11, GDPR, and HIPAA through periodic audits, validation reviews, and documentation updates. Partner with Quality Assurance teams as needed.Application Support & Lifecycle ManagementApplication support: Liaise with users and global application support teams / vendors to provide application support. Drive resolution per SLAs.User Experience (UX): Collaborate with business units to optimize application workflows and reduce friction in daily operations.Strategic Leadership & AdministrationBudgeting & Cost Control: Develop annual IT budgets, track expenditure, and identify cost-saving opportunities (e.g., cloud cost optimization, license consolidation).Team Development: Recruit, mentor, and evaluate IT staff (e.g., Systems Engineers, Support Specialists); foster a culture of continuous learning through certifications and workshops.Technology Roadmap: Define a 3-5-year IT strategy, incorporating emerging trends (AI, IoT, automation) to drive innovation and competitive advantage.Stakeholder Communication: Report KPIs (system uptime, incident resolution rates) to executives and translate technical concepts for non-technical audiences.Education & ExperienceBachelor’s degree in computer science, Information Technology, or related field;Master’s degree or MBA preferred.15+ yrsof progressive IT experience, including5+ yrs 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.Technical ExpertiseCore Infra management: Strong knowledge of network infra, server admin, endpoint devices, enterprise apps.Security: Proficiency in information security - IT / OT (familiarity with ISO 27001, NIST, SOC 2, Privacy standards).Pharma IT: Deep expertise on pharma IT standards, system qualification/validation (GAMP lifecycle, 21 CFR Part 11).Site IT ops: Hands on experience in managing devices, monitoring systems, handling incidents, deploying updates.OT: Understanding of OT systems including lab equipment integration (HPLC, SCADA, etc.), network connectivity, backups, retrieval etc. Experience assuring data integrity within OT-driven workflows and production processes.Regulatory KnowledgeIn-depth understanding ofGMP, GCP, GLP, and21 CFR Part 11requirements for electronic records and signatures.Experience preparing for and responding to regulatory audits (FDA, EMA, ISO).Soft SkillsLeadership: Ability to inspire teams, manage conflict, and drive accountability in high-pressure environments.Problem-Solving: Analytical mindset for troubleshooting complex technical and compliance challenges.Communication: Good verbal & written skills for collaborating with technical teams, executives, external partners.The anticipated salary range for this position inNew Jersey is $139,000.00 - $165,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.Physical RequirementsThe physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.Search Firm Representatives Please Read CarefullyLupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails

Created: 2025-11-10