Senior Director, Quality Systems and Data

Role Overview

• Define and implement the vision and strategy to translate Quality standards into innovative, compliant, and efficient R&D Quality processes that drive operational excellence and value creation.
• Oversee, and optimize core Quality Processes, including Documentation, Change Control, Deviation, CAPA, GMP Training, phase appropriate QMS implementation, Quality Council, Data Management.
• Accountable for ensuring robust, simple and standardized quality processes, change management and deployment across R&D, including implementing digital data enhancements and foundations.
• Ensure quality management for validation and qualification of equipment, facilities and computerized systems in alignment with regulatory and company global requirements.
• Drive digital transformation initiatives, leveraging GPS principles to improve systems, governance, data analytics, and reporting capabilities.
• Establish and monitor key performance indicators (KPIs) for Quality Systems and Processes to ensure effective quality governance and continuous improvement across operations.
• Foster a culture of learning and capability development by sponsoring initiatives such as Learning Zone, Training Academy, and Competency-Based Learning models.
• Lead the development of the Quality R&D QS&D team by enhancing skills and competencies, managing individual and team performance, and fostering behaviors aligned with GSK’s culture and leadership expectations.
• Drive data management excellence, by promoting a culture of accountability through governance, training and awareness initiatives.
• Provide strategic guidance to ensure data-related projects uphold ALCOA principles and aligned with organizational objectives.
• Provide support during regulatory inspections, global audits, and internal audits, conduct site operations oversight through GEMBA walks or other effective methods to ensure compliance and operational excellence.

Requirements

• Bachelor’s degree
• 10 years’ experience in Quality function in a highly regulated environment
• Experience of working at a senior level across various geographical regions and different cultures.
• Experience in strategy development and deployment, change / stakeholder management and business improvement.
• 5 years’ leadership experience across functions and organisational levels.
• Experience in the areas of Quality Management Systems as well as current/emerging regulatory and legal requirements governing the manufacturing, supply and distribution of products

Benefits

• US employees are eligible for an extensive benefits program