Quality Manager - Pharmaceutical and Medical Devices

Quality Manager

Job Description Summary

The Quality Manager responsible for handling technical complaints is tasked with investigating and managing technical complaints raised by clinical investigator sites regarding Investigational Medicinal Products (IMPs) and Medical Devices.
Support data integrity incidents, manage escalations, and contribute to global DI (Data Integrity) networks and initiatives.

Job Description

Key Responsibilities

• Collaborate with cross-functional teams to gather data, lead, and perform Root Cause Analysis to identify the likely root cause of events.
• Review and approve complaints as the site Investigation approver.
• Manage multiple investigations concurrently.
• Periodically analyze trends in technical complaints.
• Participate in audits and inspections, including inspection readiness activities.
• Handle data integrity escalations.
• Implement and drive global Data Integrity (DI) network initiatives

Essential Requirements

• More than Over 10 years of practical experience in the chemical/pharmaceutical industry or over 5 years of experience in pharmaceutical operations. In-depth knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes-.
• Proficient in conducting Root Cause Investigations. Effectively collaborate with the Investigation team to ensure timely completion.
• Experienced in cGMP manufacturing, Quality, and Compliance.
• Action-oriented with strong skills in building relationships, problem-solving, planning and organizing, conflict management, coaching, and analytical thinking.
• Capable of completing routine tasks with minimal direction
• Fast learning abilities, able to manage investigations related to small molecule, biologic and CGT products as well as medical devices, packaging and distribution related topics
• Able to promptly communicate roadblocks and challenges, ensuring timely delivery of investigations.
• Excellent verbal and written communication skills., Project Management
• Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including EU-GMP guidelines

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

Experience Level

Senior Level