Onsite Quality Process and Data Director

Posted 19 hours ago

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About the role

  • 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.

Job title

Quality Process and Data Director

Job type

Experience level

Lead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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