Quality Lead / Senior Validation Engineer

Verista is seeking a Quality Lead / Senior Validation Engineer to support the QISM group at the client site, focusing on IT Infrastructure and Clinical Operations areas. This role involves working closely with operational functions, DTE (IT), and other GxP QA groups to provide oversight of computerized system implementation, maintenance, and retirement. The position requires reviewing and approving computerized system lifecycle documentation, as well as providing Part 11/ Annex 11 and data integrity expertise to key stakeholders.

Key responsibilities include:

• Understanding regulations for computerized systems in GxP areas
• Participating in system implementation projects
• Reviewing and approving system lifecycle deliverables
• Consulting with QISM team members and stakeholders
• Identifying and escalating areas of risk or non-compliance
• Performing Periodic Review activities of Computerized Systems
• Supporting regulatory inspection preparedness
• Performing Infrastructure Qualification activities

Verista offers a high-growth potential in a fast-paced organization with a people-focused culture. The company provides competitive pay, performance-based incentives, and a comprehensive benefits package including health insurance, retirement plans, and paid time off.

Verista's mission is to empower growth and innovation within the scientific community and help solve pressing healthcare challenges. They value empowering colleagues, committing to client success, doing the right thing, fostering an inclusive environment, and continuous learning.

Join Verista to make an impact in the life sciences industry and be part of a team dedicated to improving lives through innovative solutions and services.