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Senior Director, Information Technology (BioPharma Industry)

Morristown, NJ
onsite
Permanent / Full Time
210000 - 255000 USD / Yearly
The Senior Director, Information Technology will lead enterprise technology strategy, infrastructure, cybersecurity, GxP validation, SOX compliance, and the business application roadmap for a growing late-stage clinical biopharmaceutical organization transitioning toward commercialization. This role will architect scalable technology capabilities, establish practical governance, and align IT with business objectives. The leader will manage a small internal IT team, oversee managed service providers and consultants, and partner with executive leadership, functional leaders, auditors, and regulatory stakeholders. Key Responsibilities<ul><li>Develop and execute the IT strategy, roadmap, budget, and investments in alignment with corporate objectives; communicate strategy, risk, and progress to executive, Board, and Audit Committee audiences.</li><li>Serve as a strategic IT partner to business leaders, translating operational and regulatory needs into technology solutions and measurable outcomes.</li><li>Own the Computer System Validation (CSV) program for GxP systems, including validation strategy, risk assessments, IQ/OQ/PQ documentation and execution, periodic reviews, and validated-state change control in accordance with 21 CFR Part 11 and GAMP 5.</li><li>Own SOX IT General Controls, including logical access, change management, and IT operations; oversee control design, walkthroughs, evidence collection, remediation, and auditor coordination.</li><li>Maintain audit and inspection readiness for IT systems, records, and data integrity.</li><li>Establish lightweight IT governance for project intake, prioritization, tracking, and status reporting.</li><li>Develop business cases and investment plans for infrastructure, security, compliance, and control improvements.</li><li>Develop project plans and review system specifications, designs, and test results against business requirements.</li><li>Evaluate and manage technology vendors and service providers, including negotiating IT outsourcing agreements.</li><li>Lead the cybersecurity program through managed security providers and consultants, covering risk assessments, incident response, forensic analysis, network/application/platform security, penetration testing, vulnerability management, endpoint protection, and data loss prevention.</li><li>Develop and enforce IT policies, procedures, and operating instructions supporting company SOPs, 21 CFR Part 11, SOX, and protection of intellectual property.</li><li>Oversee the IT service desk provider, manage escalations, and provide hands-on support when necessary.</li><li>Lead and develop a small internal IT team while managing an extended ecosystem of service providers, consultants, and validation partners.</li><li>Partner with leadership to identify high-value AI and automation opportunities and develop an adoption roadmap.</li><li>Evolve AI governance and acceptable-use policies covering data classification, confidentiality, intellectual property, vendor/model due diligence, human oversight, and documentation.</li><li>Evaluate and implement AI capabilities within existing platforms, including Microsoft 365 Copilot and AI functionality embedded in validated life sciences and ERP systems, with validation impact assessments as appropriate.</li><li>Drive responsible AI adoption through training, guardrails, and internal champions while managing security, quality, and regulatory risks.</li></ul>
2026-08-17T00:00:00Z