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.
Gujarat :
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