Quality Lead/ Lead Validation Engineer

Verista is seeking a Quality Lead/ Lead Validation Engineer to support the QISM group at their client, 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.

Key Responsibilities:

• Review and approve computerized system lifecycle documentation
• Provide Part 11/ Annex 11 and data integrity expertise
• Participate in system implementation project teams
• Consult on high-risk areas focusing on patient safety, product quality, and data integrity
• Perform Periodic Review activities of Computerized Systems
• Support regulatory inspection preparedness activities

Requirements:

• Bachelor's degree with relevant GxP work experience
• 8-10 years of experience performing validation activities
• Experience with Infrastructure Qualification activities
• Proficiency in Microsoft Office applications
• Knowledge of FDA/MHRA regulations, GAMP, and Agile validation methodologies
• Experience with validation of Enterprise/Lab Computerized Systems
• Strong communication skills and attention to detail

Verista offers a competitive salary range of $87,780-$140,220, along with benefits including medical, dental, and vision insurance, 401(k) with employer matching, paid time off, and various other perks. The company culture emphasizes empowerment, client success, and continuous learning in an inclusive environment.

Join Verista to make an impact in the life sciences industry and contribute to solving pressing healthcare challenges while growing your career in a dynamic, fast-paced organization.