Senior Manager IT Quality Assurance Location: Hyderabad, India (Amgen India AIN) Work Type: On-site as per site policy Role Overview: This vital leadership role involves executing complex and novel IT QA assignments requiring strategic planning and innovative techniques. You will oversee GxP system reviews and risk assessments per Amgen's quality policies and regulatory standards. As Senior Manager, you will supervise and mentor staff across multiple IT QA workflows, with a focus on compliance, continuous improvement, and cross-functional collaboration. Focus Areas: Computer System Validation (CSV): In-depth knowledge of 21 CFR Part 11, EU Annex 11, and GAMP standards. Audit Trail and Periodic Review Oversight: Ensure compliance, system integrity, and risk assessment. Supplier Management: Oversee vendor selection, qualification, contract management, and software delivery. Quality Management System (QMS): Ensure compliance for computerized systems, maintain documentation, and drive process improvement. Key Responsibilities: Lead and mentor IT QA staff managing GxP activities across global time zones. Guide team in conducting periodic reviews and audit trail assessments. Manage validation processes, including change control, validation deliverables (e.g., Validation Plan, Test Strategy, Summary Report). Perform supplier management for computerized systems and other validated systems. Review and approve failure investigations and CAPA for computer systems. Act as Business Owner for QA-owned systems (e.g., SAP QM, Veeva, Kneat). Support regulatory inspections and act as quality contact. Utilize tools like HP ALM, Jira, Confluence, TrackWise, and document management systems. Additional Responsibilities: Apply risk-based decision-making to IT systems and processes. Determine system/process requirements and validate deliverables. Review SOPs, validation documents, and QMS records (Deviation/CAPA). Analyze complex problems using multiple data sources and analytical tools. Track and report on IT QA metrics, recommend quality improvements. Escalate critical decisions, ensuring timely resolution and compliance. Basic Qualifications: Master's Degree with a minimum of 10 years in Software & Systems Quality Assurance (including 5 years of team leadership ) OR Bachelor's Degree with a minimum of 14 years in Software & Systems Quality Assurance (including 5 years of team leadership ) Strong understanding of GxP compliance for information systems Familiarity with industry standards, SDLC principles , and cross-functional team leadership Willingness to work in different time zones or outside standard hours Preferred Skills: 35 years experience training others in QA activities listed above Demonstrated ability to develop and improve training programs Strong collaboration mindset and ability to work across functions
