Career Opportunities: Quality Operations & Clinical Development Fellowship at Novartis

Job Summary

Novartis, a global leader in the pharmaceutical industry, is currently seeking motivated professionals for two distinct career paths based in Hyderabad: a Quality Operations Specialist/Analyst and a Clinical Development Fellow. These roles offer a unique opportunity to contribute to high-impact projects in quality assurance, GMP compliance, and clinical research. Whether you are an experienced professional or a recent postgraduate, these positions provide an environment of innovation, professional growth, and global collaboration.

Role 1: Quality Operations (Specialist/Analyst)

This role is designed for professionals focused on maintaining the highest standards of pharmaceutical quality and regulatory compliance.

Key Responsibilities:

• Ensure full compliance with cGMP standards and the Novartis Quality Management System (QMS).
• Manage QC release activities, including inspection plans, Certificates of Analysis (COA), and Certificates of Conformance (CoC).
• Author testing monographs and conduct rigorous impact assessments.
• Execute Nitrosamine risk assessment reports (Step 1 & Step 2).
• Perform statistical analysis, track performance trends, and manage business reporting.
• Maintain continuous audit readiness for both internal and regulatory inspections.
• Uphold GxP and data integrity standards across all operational processes.

Requirements:

• Educational background: B.Pharm, M.Pharm, MSc, Engineering, or MBA.
• Minimum of 3+ years of professional experience in QA, QC, or pharmaceutical manufacturing.
• Expertise in GMP, QMS, and regulatory compliance.
• Proven ability to work effectively with global stakeholders and in audit-heavy environments.
• Salary Range: ₹6 LPA – ₹12 LPA (commensurate with experience).

Role 2: Clinical Development Fellowship (2-Year Program)

This is a specialized two-year postgraduate fellowship designed to provide immersive training in the end-to-end drug development process, beginning September 1, 2026.

Key Responsibilities:

• Develop essential clinical trial documentation, including CTP, ICF, CRF, and CSR.
• Provide support for clinical data reviews and comprehensive medical analysis.
• Draft patient safety reports and prepare documentation for regulatory submissions.
• Contribute to clinical study reports and academic publications.
• Collaborate on global clinical development programs across therapeutic areas such as Oncology, Neuroscience, Gene Therapy, Cardiovascular, Metabolism, Immunology, and Global Health.

Requirements:

• Educational background: MD, PharmD, or MSc (Life Sciences).
• Must have completed graduation within the last 2 years.
• A strong passion for clinical research, trial management, and scientific thinking.
• Excellent communication skills, problem-solving abilities, and stakeholder management skills.
• Stipend Range: ₹8 LPA – ₹15 LPA.

Why Join Novartis?

• Global Impact: Work with a leading pharmaceutical innovator on cutting-edge therapies.
• Professional Development: Gain international exposure to complex regulatory frameworks and global clinical trials.
• Collaborative Culture: Engage with diverse, high-performing teams in a supportive work environment.
• Career Advancement: Build a long-term foundation for a career in drug development, QA, or clinical research.

How to Apply

We invite interested and qualified candidates to apply through the official Novartis careers portal. Please ensure your resume is updated to highlight relevant experience and skills.

• Apply for Specialist/Analyst – Quality Operations
• Apply for Clinical Development Fellow (2-Year Program)

Novartis is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.