Job Title

Operational Quality Lead-LOC India

Job Purpose

• Responsible for overseeing and continually improving the Quality Management System (QMS) and related operational activities to ensure compliance with applicable regulations and standards, drive process efficiency, and support product quality and patient safety
• This role exists within the commercial Local Operating Companies to ensure that the mandated GSK Quality Management System (QMS) requirements for commercial operating units are met. The function is critical to the effective management of systems and activities that are essential or have a direct impact on product quality and regulatory compliance.
• The job holder is expected to Lead and sustain effective Operational Quality across assigned Logistics Service Providers (LSPs)-[CFAs, Transporters, Third Parties] and provide QMS support to LOC India.

Key Responsibilities

Operational Quality:

• Drive effective implementation and sustenance of QMS across assigned LSPs by conducting structured GEMBA walks, performing robust gap assessments against defined quality standards, and proactively identifying and mitigating quality risks to ensure consistent, compliant, and audit‑ready LSP operations.
• Review and approval of QMS documentations (Change controls, Deviations, SOPs, protocol, report etc.) of LSPs as applicable.
• Conduct comprehensive quality due diligence for new LSP sites by assessing readiness against GDP, Good Warehouse Practices, to support informed onboarding and approval decisions.
• Participate in GMP audits of warehouses/CFA by acting as GMP audit and CAPA Coordinator.
• Third Party management: Act as local process owner for Third Party Incident Management; covering record tracking, trending, timeline adherence, and Updates and escalations to the LOC Quality Council as applicable.
• Establish and maintain Quality Agreements (QA/IQA/SLA) to ensure compliant third‑party engagement.
• Product Supply & Local disposition: Ensure timely local quality release in line with Quality and Regulatory requirements; liaise with manufacturing sites for queries. Ensure process is in place for disposition of pharma (Imported, Local) and  vaccines( Imported)as per current batch release procedure.
• Repacking Oversight: Ensure end‑to‑end accountability and oversight of all related activities, with appropriate governance in place to ensure that third‑party activities comply with QMS requirements and applicable local regulatory standards.
• Validation/Qualification: Coordinate quality review for storage/transport validation and calibration at CFA/CWH; manage qualification documentation. To support in review of calibration activity at CFA/CWH. To support/document in activities related to Protocol and report for Qualification process eg passive box, vehicle, storage area etc.
• Global Distribution Incident Management: Ensure accountability of the process by providing end‑to‑end oversight for the related activities to ensure management of distribution incidents as per the PGSOP.
• Quality Alert/Quality Bulletin: Support the process owner, to ensure scope of Quality Alert or Quality Bulletin and determine its applicability for the LOC
• Reference standard: Ensure accountability of the process by providing end‑to‑end oversight for the related activities (e.g., coordination with Regulatory Affairs for procurement of test licenses, facilitation of import of working/reference standards, and ensuring timely availability of reference standards for regulatory and customs agency requirements).
• Distribution Risk Assessment: Ensure the DRA is established, reviewed, and approved, with appropriate consultation provided, integrated into local SOPs, and managed in line with the Risk Management System for identified distribution risks.

Quality Systems-QMS Aspects:

• Lead and Provide end to end Oversight of QMS processes, including QMS implementation, Change Control, Complaint and counterfeit management, third‑party incidents, deviations, RCA, and CAPA, while acting as the QMS Champion to ensure effective risk management and compliance with GSK QMS, GMP/GDP, and local regulations.
• Support LOC Quality by monitoring and reporting Quality KPIs, ensuring data integrity and timely risk escalation, and driving effective implementation, maintenance, and continuous improvement of the QMS across office and warehouse operations.
• Change Controls, Deviations, and CAPAs: Review and approve activities to ensure robust root cause analysis (RCA) and timely, effective CAPA closure.
• Auditing: Maintain MM audit universe and schedules; oversee reports, CAPA and effectiveness checks.
• SOP: Maintain compliant local procedures in line with GSK QMS, GMP/GDP, and regulatory requirements, ensuring data integrity.
• Complaints & Counterfeit: Ensure compliant complaint management, trend monitoring, AE linkage, and effective counterfeit control with timely LIC/PIRC escalation.
• Training: Track training effectiveness and ensure role‑based competency.
• Incident Management: Maintain a documented product incident management process with clear escalation, integration with Quality Council and country PIRC, and ensure staff are trained on local and global PIRC processes.
• Documentation: Ensure secure storage and retention of LOCQ records per GSK policy, with all LOCQ processes and systems compliant with Data Integrity requirements.
• QMS Champion: Assess applicability of GQP/GQSOP/PGSOP and monthly QMS updates, conduct and approve gap analyses, IA tools, and action plans, and track implementation to timely closure. Interface with central QMS teams, report status to Quality Council and senior leadership, monitor QMS effectiveness, track target dates, and drive continuous improvement of the QMS implementation process.
• Risk Management (RMPO): Accountable for local RMS administration, ensuring proactive identification, assessment, control, and escalation of all quality risks. Conduct RMCB meetings, maintain quality risk registers, track mitigation plans and timelines, and escalate significant or overdue risks to RMCB and Quality Council. Act as RMPO for LOCQ India, support India RMPO reporting to Supply Chain and Regional Quality Councils and communicate risk status and action plan progress to functional heads. Administer RMS access, prepare RMCB dashboards and summaries, coordinate meeting materials and minutes, and drive annual process review and continuous improvement.
• KPI Management & Reporting: Monitor, analyze, and report Quality KPIs to assess QMS effectiveness, identify trends, and drive timely corrective actions; collate, govern, and publish manual KPIs, ensuring immediate escalation of adverse trends.

People Management:

• Manage day‑to‑day LOC Quality activities, including resource allocation, workflow management, prioritization of projects, and delivery of departmental initiatives.

• Develop and coach team members while fostering a strong quality culture across LOC.

Other Responsibilities & Backups

• Perform QMS gap assessments, participate in governance forums (QC, RMCB).
• Complete mandatory training before task execution.
• Ensure that all internal procedures and systems which are in LOCQ are followed and complied.
• Preparation, revision of LSOPs as per requirement.
• Any additional responsibility assigned by the line manager as and when required.
• Serve as backup for the assigned processes

 Knowledge/ Education / Experience Required

A. Educational Background
1. Minimum Level of Education - Post-Graduate in Science/ Pharmacy discipline

Area of Specialisation - Strong understanding and experience in Quality Assurance systems and thorough knowledge of regulatory requirements.

B. Job-Related Experience

Minimum Level of Job-Related Experience required

• Minimum 10-12 years’ experience within the Pharmaceutical / Consumer healthcare industries, preferably in the capacity of a senior quality specialist or a manager.
• Strong understanding and experience in Quality Assurance systems and thorough knowledge of regulatory requirements.
• Strong understanding of and experience in Quality Assurance systems particularly in the areas of batch release, product incidents and performing audits.
• Strong knowledge of regulatory requirements about GMP/GDP
• Good knowledge on effective Quality documentation systems   

C. Other Job-Related Skills/Background

• Professional written and verbal communication skills. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization.
• Knowledge of cGMP / Documentation/ Regulatory requirements and Quality Management Systems.
• Breadth in quality systems principles and practical application, good knowledge and demonstrated application of Quality and risk management principles and tools.
• Ability to influence and motivate stakeholders at any level of the LOC organization
• Good team player – works well in cross-functional teams.
• People management and development skills.
• Good time management skills, with ability to multi-task and work under pressure.
• Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized.
• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods.
• Flexible thinking – able to challenge and see views from different perspectives.
• Ability to self-motivate and be resilient and focused under pressure.
• Able to effectively enable and drive change across cross functional stakeholders.
• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook.

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 [email protected] to discuss your needs.

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