Quality Lead/ Lead Validation Engineer - 5122

Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Quality Lead Responsibilities:

This position will be responsible for supporting the QISM group at the Client, specifically focused on IT Infrastructure and the Clinical Operations areas. This position will be working closely with the operational functions, DTE (IT), and other GxP QA groups to provide oversight of computerized system implementation, maintenance, and retirement used in these areas. This role will review and approve computerized system lifecycle documentation as well as provide Part 11/ Annex 11, and data integrity expertise to key stakeholders internal to the Client.

• Has understanding of regulations pertaining to the implementation and use of computerized systems in all GxP areas

• Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5

• Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas

• Consults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity

• Identifies and escalates areas of risk or non-compliance to manager / leadership team

• Participates in performing Periodic Review activities of Computerized Systems

• Provide support to regulatory inspection preparedness activities as needed

Requirements

MINIMUM QUALIFICATIONS:

• Experience performing …