The Senior Director, Information Technology will lead enterprise technology strategy, infrastructure, cybersecurity, GxP validation, SOX compliance, and application roadmaps for a late-stage clinical biopharmaceutical company transitioning to commercialization. This hands-on leader will scale capabilities, establish governance, manage a small internal team alongside MSPs/consultants, and align IT with corporate goals while partnering with executive leadership, auditors, and regulatory stakeholders.Key QualificationsCommercial Launch Experience: Must have led an IT organization through a BioPharma commercial launch (e.g., Phase 3 through launch/commercialization).Compliance & Technical Depth: Deep, hands-on experience in GxP (21 CFR Part 11, GAMP 5) and SOX environments. Comfortable executing work directly, not just delegating.Cybersecurity & Risk: Proven success overseeing cybersecurity programs, threat management, compliance, and risk frameworks.Strategic Business Partnering: Strong track record collaborating with executive and cross-functional leadership to translate business needs into technology solutions.Key ResponsibilitiesStrategy & Leadership: Develop and execute the IT roadmap, strategy, and budget. Present risk, progress, and investments to executive leadership and Audit/Board committees. Build lightweight project intake and prioritization governance.GxP & Quality Validation: Own the Computer System Validation (CSV) program, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and change control in accordance with 21 CFR Part 11 and GAMP 5. Maintain audit readiness and data integrity.SOX Compliance: Manage IT General Controls (ITGCs) covering logical access, change management, and operations. Coordinate auditor walkthroughs, evidence collection, and remediation.Cybersecurity & Operations: Direct managed security service providers (MSSPs) on incident response, vulnerability management, penetration testing, endpoint protection, and DLP. Develop IT policies to protect corporate IP.Infrastructure & Helpdesk: Oversee infrastructure, Windows/Azure environments, and IT helpdesk vendors, providing hands-on escalation support when needed.AI & Innovation: Partner with leadership to identify high-value AI/automation opportunities (e.g., M365 Copilot, ERP/validated system AI capabilities). Evolve AI acceptable-use policies, vendor due diligence, and CSV impact assessments.Vendor & Team Management: Lead a small internal team while optimizing an ecosystem of MSPs, validation partners, and software vendors. Negotiate IT outsourcing agreements.
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