Focus Areas Computer System Validation (CSV) with a strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Strong understanding of periodic reviews and audit trail assessments for computer system validations, ensuring compliance, system integrity, and risk identification. Manages supplier relationships for software applications, including vendor selection and qualification, contract management, and ensuring timely and quality software delivery. Oversees the Quality Management System (QMS) for computerized systems, ensuring compliance, documentation, and continuous process improvement. Responsibilities Strong project management skills with experience supervising quality professionals working with cross functional and global stakeholders across multiple time zones. Develop, Mentor, and oversee staff and day-to-day GxP activities. Assess and guide the team in performing Periodic Review of Systems and Audit Trail Reviews. Manage change controls, validation and review and approval of validation deliverables per procedure (e.g. Validation Plan, Test Strategy, Validation Summary Report, etc.). Supplier Management activities for Computerized Systems and other validation disciplines/processes (e.g. Equipment, Analytical, etc.) Support, review and approval of failure investigations & CAPA as a Quality Contact pertaining to Computer Systems. Business Owner activities for systems owned by Quality Assurance (e.g. SAP QM, Veeva, Kneat). Participation and support of regulatory inspections as needed. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems. The following are some examples of tasks for the position Strong understanding of Risks Assessment and how to apply risk-based decision making to all processes related to IT systems. Determine and establish requirements for system/equipment or processes. Act as a reviewer and approver for SOPs, validation deliverables and /or QMS related records (Deviation/CAPA). Review and Approve System Life Cycle Documents (i.e. Validation deliverables). Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. Leverages qualitative insights and quantitative research, analyzes trending data, and utilizes forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance. Anticipates and prevents potential problems. Independently develop solutions that are thorough, practical and consistent with functional objectives. Provides management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards. Bring topics and critical decisions to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes compliance. Basic Qualification Masters degree with a minimum of 10 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration) OR Bachelors degree with a minimum of 14 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration). Strong understanding and ability to apply GxP requirements in Information systems. Possesses a strong understanding of industry standards and business principles. Contributes to work group/team by ensuring quality of tasks/ services provided by self and others. Candidate may need to work hours outside the standard workday or work in different time zones to support business needs. Preferred skills Demonstrated experience (3-5 years) training others in activities outline above. Establish/Improve and actively participate in training curriculum and delivery of this material.