Validation Lead – AI-Driven CSV/CSA & IT Compliance

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 64,500 - 151,800; Full time

Benefits offered by this job

Comprehensive benefits program

401(k) participation

Company bonus eligibility

Job summary

Initial Therapeutics, Inc. is seeking a Manager - Validation Lead in Indianapolis to drive computer system validation activities. You will lead automation and innovation using AI tools while ensuring compliance and quality. Ideal candidates will have 8-10 years of experience in CSV within the life sciences sector, a Bachelor's degree in computer science or IT, and strong leadership skills in compliance initiatives. The role offers flexible hours and the opportunity to work on meaningful projects that improve lives.

Qualifications

• In-depth knowledge of regulations related to CSV and GxP.
• 8-10 years of experience in CSV in pharmaceuticals or life sciences.
• Hands-on expertise in preparing validation deliverables.

Responsibilities

• Drive innovation using AI and automation for validation processes.
• Lead IT system validation and ensure compliance.
• Collaborate with cross-functional teams for risk mitigation.

Skills

Knowledge of CSV regulations

Expertise in validation processes

Strong analytical skills

Experience with automation tools

Effective communication

Education

Bachelor’s degree in computer science or IT

Tools

Jira

ServiceNow

Veeva

Job description

Initial Therapeutics, Inc. is seeking a Manager - Validation Lead in Indianapolis to drive computer system validation activities. You will lead automation and innovation using AI tools while ensuring compliance and quality. Ideal candidates will have 8-10 years of experience in CSV within the life sciences sector, a Bachelor's degree in computer science or IT, and strong leadership skills in compliance initiatives. The role offers flexible hours and the opportunity to work on meaningful projects that improve lives.