Quality Process and Data Director overseeing R&D Quality systems and managing process enhancements at GSK. Leading initiatives to ensure compliance and operational excellence within quality management frameworks.
Responsibilities
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.
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