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Senior Manager- IT Quality

4 weeks ago

Hyderabad, Telangana, India Amgen Technology Private Limited Full time
Job Description

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

- A Master's degree with a minimum of experience in Software and Systems Quality assurance, or a Bachelor's degree with more extensive experience. Leadership experience in this area is required.
- A strong understanding and ability to apply GxP requirements in Information systems.
- A strong understanding of regulations such as 21 CFR Part 11, EU Annex 11, and GAMP standards.
- Experience with tools and systems like HP ALM, Jira, Confluence, and TrackWise.
- Experience in training others and developing training curriculum is a plus.

Competencies

- Leadership: Proven leadership skills with a passion for mentoring and developing talent.
- Problem-Solving: The ability to evaluate and interpret complex situations, and independently develop solutions that are thorough and practical.
- Strategic Thinking: Strong understanding of risk assessment and the ability to apply risk-based decision-making to all processes.
- Communication: Excellent project management, collaboration, and communication skills for working with cross-functional and global stakeholders.