Kaygen, Inc. · 1 month ago
IT QA / QA eCompliance Manager
Indianapolis, IN
Full-time
Onsite
Senior LevelKAYGEN is an emerging leader in providing top talent for technology-based staffing services. The IT QA / QA eCompliance Manager role focuses on supporting the expansion of client ERP systems while ensuring compliance with Computer System Validation standards and delivering quality oversight for manufacturing sites.
AnalyticsBig DataData ManagementInformation ServicesInformation TechnologyStaffing Agency
Responsibilities
Maintain Inspectional Readiness
Ensure supported systems are validated
Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans
Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood
Ensure all Inspection Readiness materials are current and appropriate
Provide consulting and interpretation on client processes as related to the supported computer system
Provide training to customer areas on CSV-related topics as needed
Partner with Business, Business Quality, and IT customer areas to deliver business value
Understand customer, company, and Quality priorities
Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
Engage customers and QA management in appropriate discussions of risk management
Ensure suppliers of computer systems or services meet quality expectations
Escalate computer system quality issues to the appropriate persons
Strive for and promote consistency within the CSQA Organization
Eliminate non-value-added activities in order to focus on activities which continuously improve assurance of quality
Identify opportunity for streamlining and simplification and assist in developing improved solutions
Understand external trends and potential ramifications for the supported IT area(s)
Qualification
Required
IT CSV – Validation of IT systems
IT QA / QA eCompliance Manager
Experience validating Clinical Trials Management Systems (CTMS), Statistical Analysis Systems / Reports / Tools etc
Hands-on experience with Veeva Quality Docs, ServiceNow, JIRA and Client ALM
Pharma industry experience is mandatory
Benefits
Free Healthcare Insurance
Vision and Dental Insurance
401(k) Retirement Plan
Free Life Insurance
Sick Time Off
Certifications
Mentorship Program
Referrals
Family and Wellness benefits
Continuous Growth and Career Development
Company
Kaygen, Inc.
Kaygen, an award-winning technology consulting and talent firm, assists organizations to achieve digital transformation.
Founded in 2003
51-200 employees
H1B Sponsorship
Kaygen, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (2)
2022 (3)
2021 (8)
2020 (16)
Funding
Current Stage
Growth StageLeadership Team
Anshul Chaturvedi
Founder & CEO
Rashmi Chaturvedi
Co-founder & President
Company data provided by crunchbase