PHARMAFull-time
Manager External Supply Quality
By Admin · Quality Assurance & Quality Control
MUMBAI (IN)ONSITEPOSTED: 8/28/2026
PHARMAFull-time
HIRING ORGANIZATIONGSKPharmaceuticals / Healthcare / Life Sciences
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Provide quality and compliance support for contract manufacturing organizations (CMOs) as Complaint Coordinator, Deviation Champion, Product Incident Coordinator, Data Integrity Champion, and QMS Implementation Coordinator.
Coordinate complaints by notifying manufacturing sites, supporting investigations, ensuring timely provision of complaint samples and required information, escalating critical issues, tracking CAPA implementation and complaint closure, reporting complaint KPIs to quality governance forums, and conducting annual process reviews.
Track and monitor deviations across External Supply functions, escalate critical or overdue deviations, conduct periodic reviews, report deviation KPIs, and identify process improvement opportunities.
Support Product Incident management by assisting the Product Incident Chair with incident initiation, meeting minutes, documentation uploads, GRB process initiation in PRS, meeting organization, closure activities, documentation retention, performance tracking, risk escalation, and annual process review.
Coordinate and review regulatory communications received by CMO sites and GSK, provide GSK inputs for responses, ensure timely submissions, track communications, liaise with regulatory authorities when required, and provide updates to governance forums.
Coordinate QMS implementation for External Supply India by reviewing QMS changes, assessing applicability, completing gap and impact assessments, coordinating implementation of QMS updates, reviewing SME proposals, and escalating implementation issues.
Perform QMS gap assessments, ensure relevant SOPs are revised, monitor KPI achievement, prepare and consolidate External Supply dashboards and slide packs for quality councils and management meetings, and act as Data Integrity Champion.
Maintain audit and inspection readiness, identify and log risks in the Risk Management System, conduct internal audits/self-inspections for ES Rx India, provide backup coverage for other profile activities, and perform additional responsibilities assigned by the line manager.
Technical & Domain Expertise
Requires broad and thorough technical and regulatory knowledge of pharmaceutical manufacturing and analytical techniques/processes.
Strong knowledge of cGMP, documentation, regulatory requirements, Quality Management Systems, quality-system principles, and practical quality-management tools.
Requires experience in pharmaceutical formulation Quality Assurance, market complaints, deviations, CAPA management, QMS, change management, CMO oversight, and incident management under cGMP and regulatory requirements.
Requires knowledge of Data Integrity, GxP regulations, pharmaceutical regulatory compliance, supplier quality management, supplier auditing, risk awareness, technical writing, and quality assurance.
Exposure to multiple dosage forms is expected.
Qualifications & Experience
Graduate degree in Science or Pharmacy required; postgraduate qualification preferred.
Preferably 7+ years of Quality Assurance experience in pharmaceutical formulations.
Experience dealing with state drug regulatory authorities preferred.
At least 5 years of experience handling market complaints, deviations, CAPA management, and QMS activities is expected.
Leadership & Business Impact
Demonstrate sound fact- and data-based decision-making and application of risk-management principles.
Influence stakeholders without direct authority and collaborate effectively across External Supply, CMO, regulatory, quality, and management teams.
Demonstrate strong communication, leadership, collaboration, multitasking, and problem-solving capabilities.
Support governance, compliance, inspection readiness, supplier quality, and continuous improvement across External Supply India.
Company & Inclusion Information
GSK describes itself as a global biopharma company focused on preventing and treating disease through specialty medicines and vaccines, with focus areas including respiratory, immunology and inflammation, oncology, HIV, and infectious diseases.
GSK states that it is committed to inclusion and provides recruitment-process adjustment support through its official recruitment team.
GSK explicitly states that it does not charge candidates any recruitment fee and warns candidates against fraudulent advertisements or unsolicited payment requests.
REQUIRED VERIFIED SKILLS
Data Integrity
Digital Fluency
GxP Regulations
Pharmaceutical Regulatory Compliance
Quality Assurance
Risk Awareness
Supplier Auditing
Supplier Quality Management
Technical Writing
cGMP
Quality Management Systems
Market Complaints
Deviations
CAPA Management
Change Management
CMO Oversight
Incident Management
Regulatory Compliance
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
GSK (GlaxoSmithKline) is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. The company focuses on the research, development, and manufacture of innovative vaccines and specialty medicines. GSK's products address a wide range of diseases, aiming to impact the health of millions worldwide.
TEAM SIZE: 70,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare / Life Sciences
RECOMMENDED TRAINING
1/5
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