Senior Expert Science & Technology (GxP & Compliance)
REQ-10049939
Telangana, India
Telangana (Office)
Development
Universal Hierarchy Node
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Research & Development
Full-time | Regular
No
August 25, 2025
Lead and support the establishment and maintenance of the GxP management system for ARD Line Units at the site level. Act as a liaison between local Quality Assurance (QA) and ARD Line Units, represent ARD in GxP-related committees and networks, manage compliance and project activities, coach team members, and contribute to the overall TRD strategies and goals.
Lead and oversee all activities of assigned teams/projects to meet customer needs.
Manage GMP activities ensuring compliance with cGMP, internal and external regulations.
Advise and support team heads and staff on GMP and compliance-related issues.
Monitor quality exception management and ensure timely resolution.
Establish, maintain, and monitor the GMP management system.
Support training programs and implement SOPs related to GMP, GLP, QM, HSE, ISRM, and Novartis guidelines.
Prepare, perform, and support GMP audits, and track corrective actions.
Lead initiatives focused on continuous improvement and innovation.
Perform complex tasks independently without established procedures.
Author and oversee scientific protocols, reports, lab procedures, and process SOPs.
Prepare scientific documents for external partners and regulatory registration.
Communicate effectively within and across organizational boundaries.
Lead knowledge transfer, troubleshooting, and on-site training to other departments or external contractors.
Foster scientific and technical knowledge exchange internally and externally.
Mentor and coach scientific associates.
Present scientific and technical results internally.
Contribute to publications, presentations, and patents.
Ensure projects meet quality, cost, and timeline targets.
Optimize project-related scientific/technical activities and coordinate local teams.
M. Pharm / MSc with 10+ years relevant experience OR PhD in Science (e.g., Analytical, Pharmacy, Chemistry) with 5+ years relevant experience.
Recognized expertise in GxP with both scientific and strategic background.
Understanding of drug development processes and quality principles (GMP and applicable regulations).
Clear understanding of current and future regulatory and quality expectations.
Experience working in interdisciplinary, cross-cultural, and matrix organizations is preferred.
Advanced coaching skills.
Strong track record of innovation, creativity, and problem-solving.
Excellent oral, written, and presentation skills, including scientific report writing and documentation filing.
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other, we combine to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
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Novartis is committed to providing reasonable accommodation to individuals with disabilities. If you need accommodation during the recruitment process or to perform the essential functions of the role, please email:
diversityandincl.india@novartis.com
Include the job requisition number REQ-10049939 and details of your request.
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