Quality Process and Data Director

Role Overview

• Lead the deployment and performance management processes in R&D DDS for Change Control, Deviation, CAPA, Risk Management, Management Monitoring, Quality Council and GMP training
• Responsible for leading a team that is accountable for deploying the standardized GSK quality business processes in R&D Quality and DDS, analyzing & interpreting quality system metrics and acting on the data analytics to propose process improvements and efficiencies to GBPOs
• Responsible for developing strong partnerships across R&D Quality and DDS Operational teams to ensure that compliance risks are appropriately identified, escalated, and mitigated
• Provide leadership and management of R&D SOPs associated with the quality processes to ensure the creation, implementation, and maintenance of harmonized and efficient procedures
• Ensure the continuous alignment of, compliance to, and effectiveness of R&D processes within the QMS framework and where assigned, provide capability build for R&D QMS content owners, QMS Champions and Local SMEs on phase appropriate QMS implementation
• Responsible for managing the materials required for quality council and engaging with key stakeholders across the company to prioritize support and risk mitigation
• Accountable for the content and alignment of the R&D QMS to the legislation, and supporting Pilot Plants during inspections and issue resolution
• Providing support for change management and capability build for the Pilot Plants and aligned SMEs related to our quality processes
• Supports and drives rapid resolution of technical issues escalated from R&D Quality and DDS teams which have a direct connection to one of our quality processes
• Works with Global and Regional / Local Regulatory to understand, translate and apply local regulations, being conversant with statutory obligations and GSK procedures for all regulatory requirements to enterprise quality processes
• Motivate, focus and develop the team of quality process owners, driving continuous improvement and inclusivity to ensure operational excellence

Requirements

• Bachelor’s degree
• 10 years’ post-graduate experience in the pharmaceutical / biological industry
• Minimum of 5 years in Quality
• Experience in the areas of Pharmaceutical Product Development, Quality Management Systems as well as current/emerging regulatory and legal requirements governing, research, manufacturing, supply and distribution of products

Benefits

• Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.