Senior Manager- Supplier Quality Audit Lead-GCC

Job description

JOB PURPOSE The purpose of this job role is to assure that Suppliers of Materials, Service Suppliers and Third Party Operations within the scope of QA&C meet applicable GSK and Regulatory requirements.     This is delivered by:   • Execution of remote document-based assessments of the level of compliance with regulatory expectations and GSK standards of the Suppliers of Materials, Service Suppliers and Third Party Operations in scope.  • Management of CAPA plans to close identified gaps resulting from said documented assessments.  • Maintenance of audit and user site data in GSK supplier management system.  KEY RESPONSIBILITIES Supplier assessment, approval & compliance  • Responsible for performing Quality System assessments of assigned audits within role scope; ensure that assessments are effectively prepared, conducted and reported.  • Making a risk-based recommendation on the GxP approval status and documenting the assessments in the relevant systems within the targeted timelines.   • Ensure transparent, balanced, open communication with business stakeholders to provide timely updates on audit progress and potential issues throughout the lifecycle of the audit.  • Responsible for agreement of appropriate corrective and preventive action (CAPA) plans and follow-up on the completion of agreed CAPAs within agreed timelines.   • Responsible for ensuring that all audit related documentation is communicated out within the targeted timelines and that CAPA related documents are reviewed and responded to within targeted timelines.  • Responsible for maintenance of “auditee” profiles in the relevant data systems and ensuring that all data associated with the assessment are kept current based on currently available information provided.     Risk Management  • Responsible for collating identified risks and escalating high risk issues/situations to ensure management and stakeholders understand the technical, regulatory and quality risks and that appropriate mitigating actions are identified.    Internal Quality processes  • Responsible for completion of all relevant training curriculums within the stipulated time frame.  • Responsible for following the relevant QAC procedures.  • Remain current with technical processes, industry trends and changes in the regulatory and external environment, as needed.  RELEVANT EXPERIENCE REQUIRED • At least 10 years of experience in a pharmaceutical/Biological environment, including commercial and/or R&D operations