Job Title

Senior IT Lab Systems Delivery & Compliance Lead (Contract – 6+ Months)

Location

Headquarters – Elanco Animal Health (Indianapolis, IN)
Hybrid / Onsite presence required as needed

Engagement Type

Contract – Minimum 6 months (extension possible)

Position Summary

Elanco Animal Health is seeking a senior-level IT professional 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 Elanco IT Lead (North America-based) who will oversee day-to-day alignment.

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

Scope of Work

1. Delivery of New Local Computerized Laboratory Systems

Deploy and configure local laboratory systems including:
- Laboratory instruments and associated software
- Workstations and servers
- Interfaces and network components
Ensure alignment with:
- Elanco IT architecture standards
- Information Security requirements
- Computer Systems Quality (CSQ) validation standards
Coordinate infrastructure provisioning (hardware, hosting, networking)
Support system onboarding, access management, and operational readiness
Execute structured change management processes including:
- Veeva business change workflows
- ServiceNow release/change management
- Charter creation and governance approvals
- SARB presentation (if required)

2. Compliance Assessment of Existing Systems

Assess HQ laboratory computerized systems against:
- Computer Systems Quality (CSQ) requirements
- Validation lifecycle standards
- IT Security standards
- IT architecture/network compliance
Identify compliance gaps and risks
Document findings and remediation requirements
Support audit readiness activities

3. Validation & Remediation Execution

Lead or support the following validation lifecycle activities:

Validation Risk Assessment (VRA)
Validation Plan development
Requirements / Design / Functional Specifications
DRP / BCP documentation
Security Plan documentation
IQ/OQ protocol approval, execution, and reporting
PQ protocol approval, execution, and reporting
IT requirements testing (if not executed elsewhere)
Validation Summary Report

Additional responsibilities include:

Creation of IT CAPAs (Periodic Review, ARR, Audit Trail Review)
Creation/update of ServiceNow Knowledge Articles
IT Security Administration Procedures
RTO and Service Desk handover
Technical Operations RACI alignment (if required)
Verification of monitoring enablement
Post-cutover IT funding impact review

Deliverables

System delivery & configuration documentation (new systems)
Compliance assessment report (existing systems)
Prioritized remediation plan
Remediation execution evidence
Validation documentation package
Final compliance summary report

Required 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

Preferred Qualifications

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

Role Structure

Supplier executes delivery, validation, and remediation activities.
Elanco will appoint a supervising IT Lead (North America) to:
- Oversee daily work
- Serve as primary IT escalation point
- Ensure alignment with internal governance

Senior IT Lab Systems Delivery and Compliance Lead