Job Title: R&D Quality Manager
Job ID: REQ-10039553
Location: Hyderabad, India
Company: Novartis Healthcare Private Limited
About the Role:
The R&D Quality Manager will be responsible for handling technical complaints and managing investigations raised by clinical investigator sites regarding Investigational Medicinal Products (IMPs) and Medical Devices. This includes identifying root causes, implementing corrective actions, supporting data integrity (DI) initiatives, and contributing to global DI networks.
Key Responsibilities:
Investigation of Technical Complaints:
Lead the investigation of technical complaints, determine root causes, and implement corrective actions to prevent recurrence.
Collaborate with cross-functional teams to gather data and perform Root Cause Analysis.
Complaint Management:
Review and approve complaints as the site Investigation approver.
Manage multiple investigations concurrently and periodically analyze trends in technical complaints.
Data Integrity:
Handle data integrity escalations and drive global DI initiatives.
Contribute to audits, inspections, and inspection readiness activities.
Collaboration and Leadership:
Work closely with the Investigation team to ensure timely completion of investigations.
Ensure effective communication of roadblocks and challenges, ensuring timely delivery.
Essential Requirements:
Work Experience:
More than 14 years in the chemical/pharmaceutical industry or over 5 years in pharmaceutical operations.
In-depth knowledge of pharmaceutical facilities, manufacturing, and laboratory systems.
Experience in cGMP manufacturing, Quality, and Compliance, and handling Peptides.
Skills:
Strong problem-solving, planning, organizing, and coaching skills.
Excellent verbal and written communication skills.
Ability to handle investigations related to small molecules, biologics, CGT products, medical devices, packaging, and distribution.
Regulatory Knowledge:
Sound knowledge of current international regulatory regulations, cGxP requirements, and EU-GMP guidelines.
Why Novartis?
Novartis is focused on improving patients' lives through innovative science. Joining the team means becoming part of a community of passionate individuals working together to create breakthroughs in healthcare.
Diversity & Inclusion: Novartis is committed to building an inclusive environment.
Benefits & Rewards: Explore the Novartis benefits and rewards to enhance both personal and professional growth.
How to Apply:
To apply for this role, visit the Novartis Career Portal.
Additional Information
Accessibility: If you need any accommodation due to a medical condition or disability, please contact diversityandincl.india@novartis.com.
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