Senior Consultant - Digital Validation & IT Compliance

Job Title: Senior Consultant - Validation

As a Senior Consultant - Validation, you will be responsible for driving Computer System Validation (CSV)/Computer Software Assurance (CSA) activities, ensuring compliance, quality, and efficiency across Lilly computer systems following Lilly standards and processes.

You also will be responsible to drive innovation by leveraging AI, digital tools, and automation to simplify and automate CSV processes.

What you will be doing

Innovation & Automation:

• Drive innovation in validation by exploring and leveraging AI, digital tools, and automation technologies to streamline validation documentation, authoring, and review processes.
• Identify opportunities to simplify CSV/CSA activities through adoption of risk-based approaches, automation frameworks, and smart documentation solutions, reducing effort while maintaining compliance.
• Continuously evaluate emerging technologies (e.g., AI-assisted authoring, digital validation platforms) and recommend practical use cases for efficiency and quality improvement.
• Identify and drive continuous improvement, automation, and simplification opportunities in validation processes using digital tools or AI-enabled solutions.

Project Validation:

• Lead and coordinate IT system validation by managing the computer system lifecycle from validation/test planning to reporting and ensure compliance with regulatory requirements, Lilly processes and validation standards.
• Responsible for applying appropriate right sizing method/approach and determining the nature and content of deliverables in scope.
• Oversee AI/auto generated validation documents by reviewing and updating contents to ensure accuracy, compliance, and alignment with Lilly's quality management system.
• Review all the project validation deliverables authored by the project team (developer, SME etc.).
• Escalate and communicate operational issues, critical compliance findings and risks to the Information System Quality (ISQ) organization and other key stakeholders of the system.
• Educate project team members on Lilly IT processes and methodologies.
• Collaborate with cross-functional teams to identify and mitigate compliance risks, while providing guidance and training on best practices and regulatory requirements.
• Advise project team on implementation of compliance and security control requirements at the appropriate stages of system development.
• Contribute to internal and external audits, assessments or inspections.

Change Management:

• Ensures IT system change requests (CR) are executed in compliance with Local/global change control procedures.
• Review CRs and ensure the accuracy and completeness of all change requests.
• Review the impacted validation deliverables.

Access Roster, Privacy and Periodic Review:

• Facilitate and support the system custodian/owner and area management to execute access roster and periodic review followed by respective Corrective and Preventive Action (CAPA) closure.

How You Will Succeed:

• Achieving measurable improvements in validation efficiency (e.g., reduced cycle time, higher CSA adoption, increased compliance).
• Contributing to continuous improvement for documentation and validation processes for functional areas.
• Promoting simplification and harmonization across systems and geographies.
• Mentoring and coaching junior validation staff, fostering a quality culture across teams.
• Driving CSA adoption to simplify and modernize CSV, focusing on risk-based assurance rather than excessive documentation.

What You Should Bring:

• In-depth knowledge of regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems like GxP, GAMP 5, FDA 21 CFR Part 820, 21 CFR 210, 21 CFR 211, 21 CFR Part 11, EU Annex 11, ALCOA++ Principles, etc.
• Experience in leading CSV activities across the full system lifecycle (implementation, upgrades, retirement).
• Expertise in documents creation which includes, but not limited to validation plan, System Configuration, System Overview, Security Plan and validation report, etc.
• Hands-on expertise in preparing, reviewing, and approving validation deliverables.
• Strong knowledge of IT system operational compliance processes, including Periodic Reviews and Access Roster Reviews.
• Proven ability to apply risk-based validation approaches in alignment with CSA principles to balance compliance with efficiency.
• Hands-on experience with commonly used industry tools (e.g., Jira, ServiceNow, Veeva).

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.