Senior Manager- IT Quality

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, co...