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.
