Testing Lead

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. Job#: 3052466 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. Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Everforth Apex team member can provide. Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at View email address on click.appcast.io or View phone number on click.appcast.io. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered. #J-18808-Ljbffr Apex Systems