Senior Manager- IT Quality

We are seeking a highly skilled and experienced Senior Manager - IT Quality to lead our team in Hyderabad, India. This leadership role is crucial for supervising and mentoring staff while overseeing the execution of complex assignments related to Computer System Validation (CSV) . The ideal candidate will have extensive experience in Software and Systems Quality assurance and a strong understanding of GxP regulations . You will be responsible for ensuring compliance, managing supplier relationships, and driving continuous process improvements within our Quality Management System ( QMS ).

Responsibilities

• Team Leadership : Supervise, mentor, and oversee a team of quality professionals, managing day-to-day GxP activities and fostering a collaborative environment.
• Validation & Compliance : Guide the team in performing periodic reviews and audit trail assessments. You will manage change controls, and review and approve validation deliverables such as Validation Plans and Validation Summary Reports , ensuring they adhere to procedures.
• Quality Management : Serve as a Quality Contact for reviewing and approving failure investigations and CAPAs . You will also act as a Business Owner for Quality Assurance systems like SAP QM, Veeva, and Kneat .
• Supplier Management : Manage supplier relationships for computerized systems, including vendor selection, qualification, and contract management.
• Regulatory Support : Participate in and support regulatory inspections as needed.
• Process Improvement : Apply strong analytical skills to evaluate complex situations and use qualitative and quantitative data to drive continuous improvement in IT quality and performance.

Qualifications

Competencies

Skills Required

Computer System Validation, Quality Assurance, Process Improvement, Supplier Management, Leadership Skills, Strategic Planning