Supplier Quality Auditor

GSK; Mumbai; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

GSK in Mumbai is seeking a Supplier Quality Auditor to conduct audits across a diverse supplier network, ensuring GMP compliance and conformance to quality standards.

You will partner with Suppliers, Procurement, Quality and Supplier Quality Operations to define CAPAs, assess risks, maintain audit records, and support timely delivery of medicines.

This role offers exposure to global suppliers, cross-functional collaboration, and opportunities for professional growth while traveling as required.

Qualifications

• Bachelor’s degree in chemistry, pharmaceuticals, life sciences or technical discipline.
• 10 to 12 years overall experience with minimum 2 years of experience in supplier quality, quality assurance, auditing, compliance, or manufacturing within a regulated environment.
• Practical experience in planning and conducting audits and assessing supplier quality systems.
• Strong communication, stakeholder management, problem-solving, and decision-making skills.
• Proficiency with Microsoft Office and ability to adapt to digital tools relevant for audit management systems.
• Willingness and ability to travel domestically and internationally, as needed.

Responsibilities

• Plan, conduct, and report supplier quality audits and assessments to evaluate compliance with GMP, quality systems, regulatory requirements, and company standards, ensuring fair, consistent, risk-based, and compliant decision-making process.
• Provide risk-based supplier approval recommendations and ensure timely documentation of audit outcomes and compliance assessments.
• Partner with suppliers to define, implement, and verify CAPAs resulting from audits, complaints, supplier changes, or quality incidents.
• Identify, communicate, and escalation supplier related quality, technical, and regulatory risks, ensuring appropriate mitigation actions are implemented.
• Maintain accurate supplier profiles, user site information, and audit records within supplier management systems.
• Manage supplier compliance status, including marginal or conditionally approved suppliers, through formal governance processes.
• Collaborate effectively with User Site Quality, Procurement, Supplier Quality Operations teams and Suppliers on audit outcomes, CAPAs, supplier changes, and quality issues.
• Contribute to continuous improvement initiatives for supplier quality auditing processes and compliance with applicable GSK Quality Management System requirements.
• Ensure supplier audit related KPIs and compliance expectations are achieved through effective planning, execution, and follow-up of audit activities.

Skills

Auditing Techniques

GxP Regulations

Quality Risk Management

CAPA Management

Data Integrity

Technical Writing

Stakeholder Management

Cross Functional Collaboration

Education

Bachelor’s degree in chemistry, pharmaceuticals, life sciences or technical discipline

Tools

Microsoft Office

Job description

Job Description:

Business Introduction

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of manufacturing sites delivers medicines and vaccines that positively impact millions of patients worldwide. Technology is transforming how we manufacture medicines and vaccines through digital solutions, robotics, smart manufacturing, and artificial intelligence. We are looking for talented professionals who can help ensure our suppliers consistently meet quality, compliance, and regulatory expectations.

Position Summary

As a Supplier Quality Auditor, you will conduct supplier quality audits and compliance assessments across a diverse supplier network.

You will work closely with suppliers, Procurement, Quality, Supplier Quality Operations, and user sites to ensure materials and services meet regulatory requirements, GSK quality standards, and agreed specifications.

This role offers excellent exposure to cross-functional stakeholders, opportunities for professional growth and to directly contribute to the delivery of high-quality products to patients.

Key Responsibilities

• Plan, conduct, and report supplier quality audits and assessments to evaluate compliance with GMP, quality systems, regulatory requirements, and company standards, ensuring fair, consistent, risk-based, and compliant decision-making process.
• Provide risk-based supplier approval recommendations and ensure timely documentation of audit outcomes and compliance assessments.
• Partner with suppliers to define, implement, and verify CAPAs resulting from audits, complaints, supplier changes, or quality incidents.
• Identify, communicate, and escalation supplier related quality, technical, and regulatory risks, ensuring appropriate mitigation actions are implemented.
• Maintain accurate supplier profiles, user site information, and audit records within supplier management systems.
• Manage supplier compliance status, including marginal or conditionally approved suppliers, through formal governance processes.
• Collaborate effectively with User Site Quality, Procurement, Supplier Quality Operations teams and Suppliers on audit outcomes, CAPAs, supplier changes, and quality issues.
• Contribute to continuous improvement initiatives for supplier quality auditing processes and compliance with applicable GSK Quality Management System requirements.
• Ensure supplier audit related KPIs and compliance expectations are achieved through effective planning, execution, and follow-up of audit activities.

Why You

• Join a supportive team focused on practical impact, continuous improvement, and professional development.
• Gain exposure to suppliers of different commodities and cross-functional stakeholders.
• Travelling to supplier locations within India and internationally, as required.
• Play a key role in protecting product quality and supporting reliable supply to patients.
• We seek people who are curious, clear communicators, and able to build strong working relationships with suppliers and internal partners.

Basic Qualifications

• Bachelor’s degree in chemistry, pharmaceuticals, life sciences or technical discipline.
• 10 to 12 years overall experience with minimum 2 years of experience in supplier quality, quality assurance, auditing, compliance, or manufacturing within a regulated environment.
• Practical experience in planning and conducting audits and assessing supplier quality systems.
• Strong communication, stakeholder management, problem-solving, and decision-making skills.
• Proficiency with Microsoft Office and ability to adapt to digital tools relevant for audit management systems.
• Willingness and ability to travel domestically and internationally, as needed.

Preferred Qualifications

• Auditor certification or recognized audit training.
• Experience with GMP, ISO standards, and relevant regulatory frameworks.
• Experience working with external suppliers, contract manufacturers, procurement teams, and cross-functional quality stakeholders.
• Strong technical writing skills and hands on experience of new age digital and AI tools.
• Strong stakeholder management and influence without authority skills.
• Experience collaborating within global and matrix organizations.

Key Skills

Auditing Techniques, GxP Regulations, Quality Risk Management, CAPA Management, Data Integrity, Data Interpretation, Independent Decision Making, Supplier Quality Operations, Quality Management Systems, QMS Compliance, Technical Writing, Stakeholder Management, Cross Functional Collaboration, Resilience, Digital Fluency.

Skills

Data Integrity, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Quality Auditing, Risk Awareness, Technical Writing

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at [e-mail] to discuss your needs.