Job Title: Senior Manager, IT Validation & Compliance

Overview: Responsible for managing the validation implementation of IT systems and processes that support the growth of GxP capabilities. The Senior Manager is also responsible for leading validation maintenance activities for existing systems. The position requires computer system validation (CSV) and validation program experience in a regulated environment, as well as knowledge of regulations and regulatory inspections.

Key Responsibilities:

• Design & execute risk-based strategy for CSV life-cycle; position has potential for management of contract staff assigned to CSV projects
• Represent IT in close collaboration with Quality Assurance and internal business partners to determine validation requirements
• Lead development of validation plans, as well as write & execute validation protocols and other deliverables
• Ensure adherence to validation maintenance requirements, such as system periodic review
• Participate in support of SOX audits and regulatory inspections

Qualifications:

• Minimum of a Bachelor's degree is required, with a preference for a degree in a science, engineering, or IT-related field
• Minimum of 5 years working in a regulated environment and at least 2-3 years of experience in validation-related activities
• Ownership of assigned CSV activities, including quality of deliverables and project timelines
• Local travel between sites may be required
• Also required to be fully vaccinated per CDC requirements