Senior IT Applications Leader – Biotech GxP & AI Systems

Pulmovant

United States

Remote

USD 180,000 - 240,000

Full time

9 days ago
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Job summary

Pulmovant seeks a Senior IT Applications leader to manage the enterprise application portfolio, including validated GxP/clinical systems and enterprise IT apps, ensuring uptime, performance, and compliance.

You will partner with Clinical, Regulatory, Quality, Finance, and HR to translate business needs into system solutions, lead validation activities, and drive governance, data integrity, and tool optimization.

Qualifications

  • Bachelor's degree in Information Technology, Computer Science, or related field; advanced degree a plus.
  • 8+ years of IT applications experience with 2+ years in a management or team-lead capacity.
  • Hands-on experience administering GxP or validated systems in pharma, biotech, or another regulated life sciences environment.
  • Experience managing general enterprise IT applications such as ITSM platforms and M365 or collaboration tools.
  • Working knowledge of GxP, 21 CFR Part 11, and computer system validation practices.
  • Demonstrated experience managing vendors, budgets, and cross-functional stakeholders.
  • Experience managing AI or machine learning initiatives, including model validation and responsible AI and data governance principles

Responsibilities

  • Manage and maintain the enterprise application portfolio, including validated GxP/clinical systems and general enterprise IT applications, owning uptime, performance, configuration, and issue resolution
  • Lead system implementations, upgrades, integrations, and decommissions, coordinating computer system validation activities with Quality
  • Maintain application governance including change control, access management, data integrity, and system documentation such as SOPs and validation protocols
  • Partner with Clinical, Regulatory, Quality, Finance, and HR teams to gather requirements and translate business needs into system solutions
  • Manage vendors, budgets, and a team of application analysts, holding vendors accountable to performance and compliance commitments
  • Monitor system performance and incident trends, drive root-cause analysis, and identify opportunities to streamline workflows and retire redundant tools

Skills

IT leadership
Vendor management
Cross-functional collaboration
Regulated life sciences
GxP knowledge
System validation
AI governance

Education

Bachelor's degree in IT/CS
Advanced degree (plus)

Tools

M365
ITSM platforms

Job description

Pulmovant seeks a Senior IT Applications leader to manage the enterprise application portfolio, including validated GxP/clinical systems and enterprise IT apps, ensuring uptime, performance, and compliance.

You will partner with Clinical, Regulatory, Quality, Finance, and HR to translate business needs into system solutions, lead validation activities, and drive governance, data integrity, and tool optimization.

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