Job Description Summary
This role ensures GMP compliant, phase appropriate, and business aligned implementation, maintenance, and continuous improvement of Quality owned and Quality relevant digital systems (e.g., ERP and Non-ERP systems) in managing and releasing clinical supplies within Technical Research & Development (TRD).
The position delivers quality oversight, system governance, AI enabled digital leadership, and end to end process integration, ensuring regulatory compliance, data integrity, and inspection readiness. As a key interface between QA, business stakeholders, IT/DDIT, e Compliance, and global super user communities, the role also provides first line application support, manages access and training, and drives continuous improvement in quality and digital operations.
Job Description
Key Responsibilities
- Ensure Quality requirements are met in digital solutions, IT changes, and system enhancements. contribute to the IT system validation status as per the role outlined in Waterfall / Agile methodologies, oversee system lifecycle activities—risk assessments, data integrity reviews, supplier oversight, and change control.
- Partner with IT/DDIT/ e-Compliance to implement CSV/qualification strategies and project portfolios, manage cross‑system integrations to ensure accurate data flow and compliant batch‑release processes, serve as subject matter expert for ERP processes supporting clinical supply batch release.
- Maintain master data quality, inspection lot setup, specifications, release types, and batch attributes, provide first line user support, system issues, and coordinate with IT for defect resolution, support data migration verification, hyper care activities, and data integrity investigations.
- Manage user access governance (GRC, APS), onboarding, and periodic authorization reviews, lead or contribute to digital tool development, automation, and AI‑enabled quality solutions.
- Identify improvement opportunities to enhance compliance, transparency, and operational efficiency, represent QA in digital forums, governance councils, system‑design and user‑requirement discussions, develop and deliver system training, onboarding, and guidance for QA and clinical supply users, ensure systems/processes comply with GMP, GxP, QMS, and regulatory expectations.
- Review and approve SOPs, validation deliverables, system records, and quality documentation, maintain inspection‑ready documentation and support audits/health authority inspections.
- Manage deviations, investigations, and CAPAs using risk‑based decision making, maintain training curricula and ensure user qualification requirements are met.
- Lead/participate in global super‑user communities and knowledge‑sharing forums, reinforce data integrity and support digital‑first, quality‑focused culture.
Essential requirements
- Advanced degree in relevant scientific, engineering, data science, or IT discipline.
- 8+ years of experience in pharmaceutical quality, digital transformation, or related roles.
Desirable Requirements: GMP compliant
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message
Skills Desired
Business Partnering, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge