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Operational Quality Lead - Loc India

Gsk Plc
GSK plc
10-12 years
preferred by company
10 Jan. 27, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Operational Quality Lead – LOC India

Location: Worli, Mumbai, India
Function: Quality Assurance
Employment Type: Full-Time
Job ID: 434210
Experience Required: Minimum 10–12 years in pharmaceutical or consumer healthcare quality operations


About GSK

GSK is a global biopharmaceutical leader with a mission to unite science, technology, and talent to get ahead of disease together. We aim to improve the health of 2.5 billion people by the end of the decade through innovative specialty medicines and vaccines across respiratory, immunology, oncology, HIV, and infectious diseases.

We foster an inclusive, patient-centric culture where talented professionals can thrive, drive innovation, and deliver measurable impact on a global scale.


Role Overview

GSK is seeking an Operational Quality Lead – LOC India to oversee and continually improve the Quality Management System (QMS) and operational quality activities across local commercial operations. This role is pivotal in ensuring compliance with regulatory standards, product quality, and patient safety, while driving process efficiency and risk mitigation.

The Operational Quality Lead will provide end-to-end oversight of logistics service providers (LSPs), including warehouses, transporters, and third-party partners, ensuring audit-ready operations and alignment with GSK’s global QMS standards.


Key Responsibilities

Operational Quality Management:

  • Implement and sustain QMS across assigned LSPs through structured GEMBA walks, gap assessments, and risk identification

  • Review and approve QMS documentation (SOPs, change controls, deviations, protocols, reports)

  • Conduct quality due diligence for new LSP sites, assessing readiness against GDP and Good Warehouse Practices

  • Support GMP audits and coordinate Corrective and Preventive Actions (CAPAs)

Third-Party & Vendor Management:

  • Act as local process owner for third-party incident management, ensuring accurate tracking, trending, escalation, and reporting

  • Maintain Quality Agreements (QA/IQA/SLA) for compliant third-party engagement

  • Oversee product supply and local disposition, ensuring timely release and adherence to regulatory requirements

  • Provide governance for repacking, storage, transport validation, and calibration activities

Quality Systems & Compliance:

  • Lead end-to-end QMS processes including change control, deviations, complaints, counterfeit management, incident management, and CAPA

  • Monitor and report quality KPIs, ensuring data integrity and timely risk escalation

  • Act as QMS Champion, driving continuous improvement, monthly updates, gap analyses, and effectiveness monitoring

  • Maintain compliance with GMP/GDP standards, local regulations, and data integrity requirements

Risk Management & Reporting:

  • Administer local Risk Management System (RMS), identifying, assessing, and mitigating quality risks

  • Conduct RMCB meetings, maintain risk registers, and escalate critical issues to the Quality Council

  • Provide timely dashboards, summaries, and reports to senior leadership

People Leadership:

  • Manage day-to-day LOC Quality operations, including resource allocation, workflow management, and project prioritization

  • Develop, mentor, and coach team members to strengthen quality culture across LOC operations


Required Qualifications & Experience

  • Postgraduate degree in Science, Pharmacy, or a related discipline

  • 10–12 years of experience in Quality Assurance or Quality Operations within pharmaceutical or consumer healthcare industries

  • Deep understanding of Quality Assurance systems, GMP/GDP, batch release, product incidents, audits, and regulatory compliance

  • Strong experience in QMS implementation, risk management, and quality documentation systems

  • Proven ability to influence and lead cross-functional teams, manage multiple priorities, and drive process improvements


Skills & Competencies

  • Exceptional written and verbal communication, stakeholder management, and team leadership skills

  • Strong knowledge of regulatory standards and cGMP practices

  • Practical application of quality and risk management principles, QMS tools, and continuous improvement methodologies

  • High attention to detail, analytical thinking, and decision-making ability under pressure

  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) and familiarity with quality management software


Why GSK?

  • Join a global biopharma company committed to innovation, patient impact, and scientific excellence

  • Competitive salary with performance-based incentives

  • Comprehensive benefits including healthcare, wellbeing programs, life insurance, and pension plans

  • Flexible working options, modern offices, and supportive work-life balance initiatives

  • Continuous learning opportunities with mentoring, online training, and skill development platforms


Inclusion & Equal Opportunity

GSK is an equal opportunity employer. We encourage candidates from diverse backgrounds to apply and provide accommodations during the recruitment process.

Contact for recruitment adjustments: IN.recruitment-adjustments@gsk.com


Recruitment Advisory

GSK does not charge any fees during recruitment. Candidates should only engage with official GSK email domains and verify job authenticity.


Take ownership of operational quality in a leading global biopharma organization. Apply now on thepharmadaily.com to join GSK’s LOC India team and drive excellence in quality management.