This is a full-time, hybrid role located in Indianapolis, IN, for a Senior IT Lab Systems Delivery & Compliance Lead to lead the delivery of new local computerized laboratory systems and the compliance remediation of existing HQ laboratory systems.

This role requires deep experience in regulated environments (GxP), IT validation, security, infrastructure coordination, and cross-functional stakeholder engagement. The selected candidate will operate with minimal supervision and will partner closely with an assigned IT Lead (North America-based) who will oversee day-to-day alignment.

The expectation is independent execution, structured documentation, and strong regulatory awareness.

Qualifications

• 8+ years experience in regulated IT environments (pharma, biotech, medical device, or similar)
• Strong knowledge of GxP computerized system validation lifecycle
• Experience with laboratory computerized systems (instruments, interfaces, middleware)
• Hands-on experience with:
• IQ/OQ/PQ execution
• Validation documentation authoring
• IT change management (ServiceNow or similar)
• Familiarity with:
• Information Security standards
• Infrastructure coordination (servers, networking, hosting)
• CAPA processes
• Ability to operate independently with minimal oversight
• Strong documentation and stakeholder communication skills
• Experience working in global pharmaceutical or life sciences organizations
• Experience presenting to governance boards (e.g., architecture review boards)
• Prior involvement in remediation or audit recovery programs
• Familiarity with Veeva workflows and regulated IT environments

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