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Specialist - Quality Operations

Novartis
Novartis
3-6 years
Not Disclosed
Hyderabad
1 May 6, 2026
Job Description
Job Type: Full Time Education: Bachelor’s Degree or Master’s Degree in: Chemistry Pharmacy Biotechnology Life Sciences Pharmaceutical Sciences Or related scientific disciplines Skills: Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ

Specialist – Quality Operations

Location: Hyderabad (Hybrid Office Model)
Job Type: Full-Time
Experience Required: Several Years of Experience in Supplier Quality Management or Quality Operations
Industry: Pharmaceutical / Quality Assurance / Manufacturing Operations


Job Overview

We are seeking a detail-oriented and collaborative Specialist – Quality Operations to support supplier quality management and quality assurance activities within a regulated pharmaceutical environment. The selected candidate will play a critical role in ensuring supplier compliance, maintaining product quality standards, and supporting manufacturing operations through robust quality oversight and supplier partnership management.

This role is ideal for professionals with expertise in supplier quality management, GMP compliance, quality agreements, risk assessments, and pharmaceutical quality operations.


Key Responsibilities

Supplier Quality Management

  • Own end-to-end supplier quality management activities including:
    • Supplier qualification
    • Supplier monitoring
    • Supplier documentation management
  • Build and maintain strong quality-focused relationships with external suppliers and service providers.
  • Ensure suppliers comply with:
    • GMP guidelines
    • Regulatory requirements
    • Internal quality standards

Quality Agreements & Compliance

  • Draft, review, negotiate, and maintain:
    • Quality Assurance Agreements (QAA)
    • Supplier quality documentation
    • Service provider compliance records
  • Evaluate supplier change notifications and manage related:
    • Quality records
    • Change controls
    • Compliance documentation
  • Support supplier-related regulatory compliance and operational quality activities.

Risk Management & Quality Oversight

  • Perform quality risk assessments for:
    • New suppliers
    • Existing suppliers
    • Incoming materials
  • Prepare:
    • Regulatory statements
    • Annual monitoring reports
    • Quality contributions for Product Quality Reviews (PQR)
  • Ensure effective management of:
    • Deviations
    • CAPAs (Corrective and Preventive Actions)
    • Discrepant material investigations

Audit & Cross-Functional Support

  • Support:
    • Internal audits
    • Supplier audits
    • Inspection readiness activities
  • Collaborate with:
    • Manufacturing sites
    • Service delivery teams
    • Quality Assurance teams
    • Cross-functional stakeholders
  • Provide quality guidance and operational support on supplier and material-related quality topics.

Operational Excellence

  • Contribute to continuous improvement initiatives across supplier quality and operational processes.
  • Ensure timely and accurate quality documentation aligned with organizational standards.
  • Maintain high standards of compliance, accuracy, and operational efficiency.

Required Qualifications

Educational Qualifications

Required Qualification:

  • Bachelor’s Degree or Master’s Degree in:
    • Chemistry
    • Pharmacy
    • Biotechnology
    • Life Sciences
    • Pharmaceutical Sciences
    • Or related scientific disciplines

Preferred Qualifications

  • Certifications in:
    • GMP
    • Quality Assurance
    • Supplier Quality Management
    • Regulatory Compliance
    • Pharmaceutical Quality Systems
  • Additional expertise in:
    • Vendor Management
    • Quality Risk Management
    • Pharmaceutical Manufacturing Operations