Quality Manager at Novartis

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

14 Jun, 26

Salary

0.0

Posted On

16 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Business Partnering, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital Saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements Knowledge, GMP Compliance, System Governance, AI Enabled Digital Leadership, CSV, QMS

Industry

Pharmaceutical Manufacturing

Description

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 Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

This role ensures GMP compliant implementation and maintenance of Quality digital systems, providing quality oversight, system governance, and AI-enabled digital leadership for clinical supplies within Technical Research & Development. Key duties include ensuring regulatory compliance, data integrity, managing system lifecycle activities, and serving as a subject matter expert for ERP processes supporting batch release.