LI
Testing Lead
LanceSoft Inc
🇨🇦 Canada | 🇺🇸 United States
Hybrid
Staff / Principal
2 weeks ago
$109.48 / hour
- Veeva Vault
- Regulatory Compliance
- Azure DevOps
- GxP
- Health insurance
- Pension
2 weeks ago
Duration: 12 Months
Pay range:Â $109.48 - $109.48/hr.
Hybrid schedule
Job Description:
Requirements and Qualifications
•Bachelor’s degree in Life Sciences, Computer Science, or a related field.
•7+ years of software quality assurance experience with at least 3 years focused on RIM implementations (e.g., Veeva Vault RIM, or Ennov).
•Deep understanding of regulatory affairs processes, eCTD submissions, and IDMP standards.
•Hands-on experience with computer system validation (CSV) and life sciences regulatory compliance guidelines.
•Strong background in writing manual or automated test scripts and managing testing tools like Azure Dev Ops.
Key Responsibilities
•Design and execute end-to-end test strategies for RIM modules (Registration, Submissions, Product Tracking, and IDMP).
•Lead validation activities to ensure full compliance with FDA 21 CFR Part 11, GxP, and EMA data standards.
•Create and review validation master plans, test protocols, scripts, and traceability matrices.Coordinate functional, integration, user acceptance (UAT), and data migration testing across global teams.
•Manage defect lifecycles, root-cause analysis, and test status reporting for project leadership.
•Partner with regulatory operations, vendors, and business analysts to define acceptance criteria for complex regulatory workflows.
Top 3 Skills :
•Deep understanding of regulatory affairs processes, eCTD submissions, and IDMP standards.
•Hands-on experience with computer system validation (CSV) and life sciences regulatory compliance guidelines.
•Strong background in writing manual or automated test scripts and managing testing tools like Azure Dev Ops.
Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:
- Four options of medical Insurance
- Dental and Vision Insurance
- 401k Contributions
- Critical Illness Insurance
- Voluntary Permanent Life Insurance
- Accident Insurance
- Other Employee Perks
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.
Testing Lead · LanceSoft Inc