Lead Validation Specialist
4 days ago
Lead Validation Specialist Location: Remote (Preference for East Coast candidates) Salary: $125,000-$150,000/year bonus potential About the Role We're seeking an experienced Lead Validation Specialist with a strong background in clinical systems and computer systems validation to join our growing team. In this role, you'll lead validation initiatives to ensure that all systems are compliant with GxP regulations and 21 CFR Part 11, working closely with developers, QA professionals, and SMEs to support rapid development timelines without compromising quality or compliance. This is an ideal position for someone who thrives in a fast-paced, dynamic environment, enjoys mentoring others, and is eager to take ownership of validation strategy and execution in a regulated life sciences setting. What You'll Do Lead and manage the validation team, ensuring systems meet compliance with GxP and 21 CFR Part 11. Develop, execute, and maintain validation strategies and documentation for clinical systems. Collaborate cross-functionally with developers, QA, and SMEs to support validated environments. Ensure data integrity and adherence to ALCOA principles across relational databases (Oracle, MS SQL). Drive continuous improvement of validation processes to maintain audit-readiness and efficiency. Mentor and coach team members to promote excellence in validation and regulatory compliance. Support the implementation and lifecycle management of new and existing clinical systems. What You'll Bring Bachelor's degree required. 8 years of professional experience in computer systems validation within life sciences or clinical research. 5 years leading a validation team or similar function. Proven expertise with GxP and 21 CFR Part 11 compliance. Experience with SDLC, Agile methodologies, and validation of cloud-based systems. Strong technical foundation with relational databases (Oracle, MS SQL). Excellent communication, problem-solving, and organizational skills. Ability to work independently in a remote, fast-paced, and collaborative environment. Preferred Qualifications: Prior project management experience. Experience in a CRO, biotech, or pharmaceutical environment. Familiarity with cloud technologies and web-based systems. System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. M2 Ref: 558-Scientific
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