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. 

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. 

• At least 10 years of experience in a pharmaceutical/Biological environment, including commercial and/or R&D operations 

• Proficiency and experience in planning and executing audits to identify and reduce significant risks / non-compliances.  

• Knowledge of regional/global GMP and GSK quality requirements and ability to explain these and relate them to GSK manufacturing operations and supplier operations, applying good business judgment in doing so. 

• Awareness of business environment and ability to build networks and relationships with third party suppliers and internal stakeholders. 

• Proficient influencing and negotiating skills to ensure access for assessment, implementation of appropriate corrective actions, etc. 

• Good verbal and written communications skills to ensure effective relay of issues, risks and opportunities so that these are well understood by all parties and that effective action plans can be put in place to address identified issues/risks. 

• Proficiency in verbal and written English. 

• Experience with Microsoft Office applications and ability to learn and apply new software applications as required as part of role (e.g., audits management software, AI tools, remote virtual meetings management, etc.)