Supplier Quality Auditor Lead
GSK · India - Maharashtra - Worli Mumbai
GSK · India - Maharashtra - Worli Mumbai
Business IntroductionWe manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.Position Summary You will lead supplier quality audits, compliance assessments, and supplier quality improvement activities across India-based suppliers. You will work closely with suppliers, procurement, quality, manufacturing, and cross-functional stakeholders to ensure compliance with regulatory requirements, GSK quality standards, and agreed specifications. This role offers the opportunity to drive supplier quality performance, reduce supply chain risk, strengthen supplier relationships, and contribute to continuous improvement initiatives that support delivery of high-quality products to patients. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • Plan, conduct, and report supplier quality assessments and audits to evaluate compliance with GMP, quality systems, regulatory requirements, and GSK standards. • Provide risk-based supplier approval recommendations and ensure timely documentation of audit outcomes and compliance assessments. • Work with suppliers to define, implement, and verify corrective and preventive action (CAPA) plans resulting from audits, complaints, supplier changes, or quality incidents. • Monitor supplier compliance status and support governance activities for approved, conditional, and marginal suppliers. • Maintain accurate supplier quality records, audit documentation, supplier profiles, change controls, and Quality Assurance Agreement inputs within supplier management systems. • Identify, assess, and escalate supplier-related quality, technical, and regulatory risks, ensuring appropriate mitigation actions are implemented. • Lead or support third-party supplier audits and provide coaching and guidance to team members on audit expectations and best practices. • Support regulatory inspections and customer audits by providing supplier quality expertise, documentation, and compliance support. • Collaborate with Procurement, Quality, Operations, R&D, and external suppliers to ensure effective communication and resolution of supplier quality issues. • Contribute to continuous improvement initiatives, self-inspections, quality system enhancements, and supplier quality process improvements. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: • Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Life Sciences, Engineering, or a related scientific discipline. • Experience in pharmaceutical quality, supplier quality, manufacturing quality, quality systems, or GMP compliance environments. • Strong knowledge of GMP requirements, supplier qualification processes, quality systems, CAPA management, change control, and regulatory expectations. • Experience conducting supplier audits, compliance assessments, and managing supplier corrective action plans. • Ability to evaluate supplier quality risks and make risk-based compliance recommendations. • Strong verbal and written communication skills in English with the ability to influence internal and external stakeholders. • Experience working with supplier management systems, audit documentation tools, and Microsoft Office applications. • Willingness to travel to supplier sites within India and internationally as required. Preferred Qualification If you have the following characteristics, it would be a plus: • Experience working with global pharmaceutical suppliers and contract manufacturing organizations. • Lead Auditor certification, recognized auditor qualification, or equivalent supplier auditing experience. • Knowledge of global pharmaceutical regulations and supplier quality management practices. • Experience supporting regulatory inspections, customer audits, and supplier compliance programs. • Strong stakeholder management, influencing, and negotiation skills. • Experience working in a matrix organization across multiple functions, geographies, and cultures. • Familiarity with supplier risk assessments, quality agreements, change control processes, and supplier governance activities. • Advanced degree or professional qualification in a scientific, pharmaceutical, quality, or regulatory discipline. What we value in youYou are professional, curious and collaborative. You act with transparency and integrity. You are comfortable working in a matrix environment. You look for practical ways to improve supplier performance and reduce risk. You help others learn and grow.Ready to apply?If this role feels like the next step for you, we would like to hear from you. Please submit your CV and a short note describing a supplier audit or quality improvement you led and the impact it delivered. We welcome applica