In this pivotal Senior Manager Quality Assurance role within our IT Quality organization in Hyderabad, you'll be a leader, driving the execution of complex assignments that demand strategic planning and the development of innovative techniques. Your primary focus will be overseeing and mentoring a team of quality professionals, ensuring meticulous internal reviews and risk assessments of GxP systems, all in accordance with Amgen's policies and procedures. Focus Areas: Computer System Validation (CSV) : You'll bring a strong understanding of regulations like 21 CFR Part 11, EU Annex 11, and GAMP standards . Periodic Reviews and Audit Trail Assessments : Ensure compliance, system integrity, and risk identification for computer system validations. Supplier Relationships : Manage software application suppliers, including vendor selection, qualification, contract management, and ensuring timely, quality software delivery. Quality Management System (QMS) : Oversee the QMS for computerized systems, focusing on compliance, documentation, and continuous process improvement. Responsibilities: Possess strong project management skills with experience supervising quality professionals who collaborate 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 (e.g., Validation Plan, Test Strategy, Validation Summary Report, etc.). Handle Supplier Management activities for Computerized Systems and other validation disciplines/processes (e.g., Equipment, Analytical, etc.). Support, review, and approve failure investigations & CAPA as a Quality Contact pertaining to Computer Systems. Perform Business Owner activities for systems owned by Quality Assurance (e.g., SAP QM, Veeva, Kneat). Participate in and support regulatory inspections as needed. Utilize tools and systems such as HP ALM, Jira, Confluence, TrackWise, and Documentation Management Systems . Example Tasks for the Position: Possess a strong understanding of Risk 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. Leverage qualitative insights and quantitative research, analyze trending data, and utilize forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance. Anticipate and prevent potential problems. Independently develop solutions that are thorough, practical, and consistent with functional objectives. Provide management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards. Bring topics and critical decisions to management's attention and initiate and enforce necessary improvements and corrections to established systems and process compliance. Basic Qualifications: Master's degree with a minimum of 10 years of experience in Software and Systems Quality Assurance (including a minimum of 5 years experience in leading teams in this area and fostering strong collaboration) OR Bachelor's degree with a minimum of 14 years of experience in Software and Systems Quality Assurance (including a minimum of 5 years experience in leading teams in this area and fostering strong collaboration). Strong understanding and ability to apply GxP requirements in Information Systems. Possess a strong understanding of industry standards and business principles. Contribute to work group/team by ensuring the quality of tasks/services provided by self and others. Ability to work hours outside the standard workday or in different time zones to support business needs. Preferred Skills: Demonstrated experience (3-5 years) training others in the activities outlined above. Ability to establish/improve and actively participate in training curriculum and delivery of this material.