Validation Manager

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• *Travel (approximately 10%) domestic and/or international.
• *Provide strategic direction to the IT department in terms of CSV based on industry best practices, Installation Qualification, Change Control, and System Retirement.
• *As a leader within the IT organization, create a culture that drives continuous improvement by streamlining our processes to focus on activities that add value to our business and meeting client needs.
• *Further develop and continuously improve the CSV process to enhance effectiveness, efficiency and compliance.
• *Serve as the spoke person and Subject Matter Expert (SME) in all areas of CSV.
• *Ensure proper evaluation of new and existing computer systems to determine if they need to be 21 CFR Part 11 compliant and/or validated.
• *Participate in the evaluation and hiring of any third party contractors and consultants for carrying out CSV activities.
• *Ensure appropriate resolution and documented justification for any and all deviations encountered during CSV activities.
• *Represent IT Validation Services during sponsor audits or regulatory inspections, and create or approve responses for observations assigned to us by Quality Assurance.
• *Communicate and escalate critical business related issues as well as opportunities to senior management.
• *Ensure personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures pertaining to CSV.
• *Assist Project Management Office team members with resource planning, validation effort estimating, as well as reviewing project deliverables.
• Support company goals and objectives, policies and procedures, Quality Management System, and FDA regulations/ISO and other regulatory requirements.
• Keep IT senior management informed of any issues related to CSV, which requires attention.
• Undertake other reasonably related duties as may be assigned from time to time.