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Senior Expert Science & Technology (Gxp & Compliance)

5-10 years years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Full Time Education: M. Pharm / MSc or PhD in Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Senior Expert Science & Technology (GxP & Compliance)

Job ID:

REQ-10049939

Location:

Telangana, India

Site:

Telangana (Office)

Division:

Development

Business Unit:

Universal Hierarchy Node

Company / Legal Entity:

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area:

Research & Development

Job Type:

Full-time | Regular

Shift Work:

No

Date Posted:

August 25, 2025


Role Summary:

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.


Key Responsibilities:

🛠 Leadership & Oversight

  • 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.

📋 Compliance & Quality Management

  • 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.

🔄 Continuous Improvement

  • Lead initiatives focused on continuous improvement and innovation.

  • Perform complex tasks independently without established procedures.

📄 Documentation & Reporting

  • Author and oversee scientific protocols, reports, lab procedures, and process SOPs.

  • Prepare scientific documents for external partners and regulatory registration.

🧩 Communication & Collaboration

  • 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.

👥 Team Development

  • Mentor and coach scientific associates.

  • Present scientific and technical results internally.

  • Contribute to publications, presentations, and patents.

🎯 Project Delivery

  • Ensure projects meet quality, cost, and timeline targets.

  • Optimize project-related scientific/technical activities and coordinate local teams.


What You’ll Bring to the Role:

🎓 Qualifications & Experience:

  • 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.

🛠 Skills & Competencies:

  • 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.


Why Novartis?

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?

🔗 Learn more about Novartis People & Culture


Benefits and Rewards:

Explore all the ways Novartis helps you thrive personally and professionally:
🔗 Novartis Benefits & Rewards


Accessibility and Accommodation:

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.


Join Our Network:

Not the right role for you? Stay connected and be the first to hear about new opportunities:
🔗 Novartis Talent Network