Senior Manager- Supplier Quality Audit Lead-GCC

Overview

Assure that suppliers of materials, service suppliers and third-party operations within the scope of QA&C meet applicable GSK and regulatory requirements, through remote document-based assessments, CAPA management and maintenance of audit data in the GSK supplier management system.

What you'll do

• Perform quality system assessments of assigned audits within role scope, ensuring they are effectively prepared, conducted and reported.
• Make risk-based recommendations on GxP approval status and document assessments in the relevant systems within targeted timelines.
• Communicate transparently with business stakeholders, providing timely updates on audit progress and potential issues throughout the audit lifecycle.
• Agree appropriate corrective and preventive action (CAPA) plans and follow up on completion within agreed timelines.
• Ensure audit-related documentation is communicated within targeted timelines and CAPA documents are reviewed and responded to on time.
• Maintain auditee profiles in the relevant data systems and keep assessment data current based on available information.
• Collate identified risks and escalate high-risk issues so that management and stakeholders understand technical, regulatory and quality risks and mitigating actions are identified.
• Complete all relevant training curriculums within the stipulated time frame.
• Follow the relevant QA&C procedures.
• Remain current with technical processes, industry trends and changes in the regulatory and external environment, as needed.

What you'll need

• 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 and non-compliances.
• Knowledge of regional/global GMP and GSK quality requirements, able to explain them and relate them to GSK manufacturing and supplier operations, applying good business judgment.
• Awareness of the business environment and ability to build networks and relationships with third-party suppliers and internal stakeholders.
• Proficient influencing and negotiating skills to secure access for assessment and implementation of appropriate corrective actions.
• Good verbal and written communication skills to relay issues, risks and opportunities so that all parties understand them and effective action plans can be put in place.
• Proficiency in verbal and written English.
• Experience with Microsoft Office applications and ability to learn and apply new software applications required for the role (e.g., audit management software, AI tools, remote virtual meeting management).
• Post Graduate/Graduate degree in relevant science (Biology, Chemistry, Pharmacy) or Food / Chemical / Biotechnology or equivalent engineering area of expertise.

Details

• Location: Bengaluru, Luxor North Tower.