Senior Manager- Supplier Quality Audit Lead-GCC

14260 GSK India Global Services Private Limited; Bengaluru; Sur place; INR 1 200 000 - 1 900 000; Plein temps

Résumé du poste

GlaxoSmithKline plc seeks a senior QA auditor to assess supplier materials, service suppliers and third party operations for GSK regulatory compliance. You will manage CAPA plans, coordinate audit activities, and maintain data in supplier systems to uphold quality standards.

The role requires 10+ years in pharma/biological environments, strong knowledge of GMP, and excellent communication to liaise with stakeholders. English proficiency and software familiarity are essential.

Qualifications

• 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.)

Responsabilités

• Perform quality system assessments of assigned audits within role scope and document assessments.
• Provide risk-based recommendations on GxP approval status and document in relevant systems within timelines.
• Coordinate and communicate audit progress and issues with stakeholders throughout the lifecycle of the audit.
• Agree and track CAPA plans and ensure timely completion of CAPAs.
• Maintain auditee profiles and keep assessment data current in data systems.
• Escalate identified risks to management and stakeholders with mitigating actions.
• Complete relevant training curriculums and follow QAC procedures.
• Stay current with technical processes, industry trends and regulatory changes as needed.

Connaissances

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

Formation

Post Graduate/Graduate degree in relevant Science (Biology, Chemistry, Pharmacy) or Food/Chemical/Biotechnology or equivalent Engineering

Description du poste

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 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.)

EDUCATION

Post Graduate/Graduate degree in relevant Science (Biology, Chemistry, Pharmacy) or Food / Chemical / Biotechnology or equivalent Engineering area of expertise

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.

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We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.