Testing Lead

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.

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.

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.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• Other insurance plans (optional layer of financial protection)
• Employee Stock Purchase Program (ESPP)
• 401K program (contribute within 30 days of start, company match after 12 months tenure)
• Health Savings Account (HSA) on HDHP plan
• SupportLinc Employee Assistance Program (EAP) – up to 8 free counseling sessions
• Corporate discount savings program and other discounts
• On-demand training program
• Access to certification prep and a library of technical and leadership courses/books/seminars (after 6+ months tenure)
• Certification discounts and other perks for associations (CompTIA, IIBA)
• Dedicated customer service team for Consultants (benefits and resources inquiries)
• Certified Career Coach
• Full list of benefits, programs, support teams, and resources available in the Welcome Packet (provided by an Everforth Apex team member)