Title: R&D Quality Specialist
Company: Novartis
Location: India
Job ID: REQ-10050616
Posted Date: April 30, 2025
Work Type: Full-time
Function: Quality Assurance / Clinical R&D
Industry: Pharmaceuticals / Life Sciences
Job Summary:
The R&D Quality Specialist manages quality aspects of clinical programs, ensuring GxP compliance and alignment with Novartis Quality Management Systems. The role includes monitoring KPIs, supporting audits, and driving quality improvements across systems and processes.
Key Responsibilities:
Monitor and report Quality KPIs for clinical projects and programs
Support internal audits and Health Authority inspections
Manage GxP Quality systems including change control, training, risk, and escalation management
Ensure full compliance with Novartis Quality Manual and GxP standards
Track and ensure timely closure of CAPAs and escalate issues when necessary
Review and maintain quality deliverables, records, SOPs, and third-party documentation
Prepare and release GxP documentation; ensure proper filing and archiving
Contribute to inspection readiness and compliance reviews
Support the distribution of marketing samples where applicable
Ensure reporting of technical complaints or adverse events within 24 hours
Key Performance Indicators:
Timely project support and quality deliverables
Passing internal and external inspections
Effective partner/customer relationships
Early engagement in external/industry GxP efforts
Alignment with Novartis values and leadership behaviors
Minimum Requirements:
Experience in Quality Assurance, Project Management, and Operations within GxP environments
Strong knowledge in CAPA, SOPs, Risk Management, RCA, and QMS
Demonstrated skills in audit management, change control, and compliance support
Financial and business acumen (e.g., cost management)
Effective collaboration across functions and geographies
Fluent in English
Skills and Competencies:
Quality Management Systems (QMS)
Root Cause Analysis (RCA)
CAPA and Risk Management
SOPs and Compliance Auditing
Agile and Collaborative Mindset
Self-Awareness and Influencing Skills
Why Join Novartis:
Join a collaborative and quality-driven environment where your work ensures the integrity of clinical programs and helps improve patients’ lives globally.
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