Job Title
Senior GCP/PV Auditor
Job ID: REQ-10051674
Date Posted: May 12, 2025
Location: Mumbai, India (Hybrid)
About the Role
As a Senior GCP/PV Auditor at Novartis, you will lead, support, and report independent GCP/PV audits in alignment with the NVS Quality System and regulatory requirements. You will act as a subject matter expert (SME) for assigned areas, provide consultation to business units, review corrective action plans (CAPAs), and ensure compliance with GCP/PV regulations, standards, and guidance.
Key Responsibilities
Audit Planning & Execution
Develop and support a global risk-based audit strategy and program.
Lead, plan, conduct, document, and follow up on GCP/GPvP audits and assessments.
Ensure compliance with Novartis Quality Modules, regulations, standards, and quality agreements.
Prepare audit reports in alignment with Novartis requirements and timelines.
CAPA & Escalation Management
Review and approve CAPA plans for adequacy and timeliness.
Ensure appropriate escalation of critical findings to management.
Collaborate with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP) to ensure resolution.
Leadership & Guidance
Provide technical guidance, mentoring, and training to other auditors.
Lead audit teams and contribute to global compliance initiatives.
Regulatory & Inspection Support
Support Health Authority inspections and mock Pre-Approval Inspections (PAIs).
Participate in compliance investigations, inspection readiness, and quality improvement initiatives.
Research global regulatory trends and integrate them into audit strategy.
Reporting & Communication
Identify, communicate, and escalate compliance issues through appropriate channels.
Recommend remediation actions to Quality Management.
Review and approve audit reports as required.
Essential Requirements
7+ years’ experience in GCP/PV/Pharmaceutical industry or Health Authority role.
Minimum 3 years of GCP/PV auditing experience (5 years preferred).
Strong knowledge of GCP and PV regulations.
Experience with Health Authority inspections and interactions.
Ability to manage complex compliance issues independently.
Strong organizational, communication, and leadership skills.
Willingness to travel up to 60%.
Desirable Requirements
Knowledge of computer systems validation and 21 CFR Part 11 requirements.
Proven ability to lead audit teams and work in cross-functional team environments.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives, and our vision is to become the most valued and trusted medicines company in the world.
Be part of a mission-driven community of passionate professionals.
Collaborate to deliver breakthroughs that change patients’ lives.
Access a culture that values inclusivity, innovation, and continuous growth.
Learn more: Novartis People & Culture
Benefits & Rewards
Novartis offers comprehensive benefits to help you thrive both personally and professionally.
📖 Read more: Novartis Life Handbook
Commitment to Diversity & Inclusion
Novartis is committed to creating a diverse and inclusive workplace that reflects the patients and communities we serve. We encourage applications from individuals of all backgrounds.
Stay Connected
If this role does not match your experience or career goals, join the Novartis Talent Network to stay updated on future opportunities:
👉 Join the Network
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