Pharmaceutical Compliance Leader

1 month ago


Bengaluru, Karnataka, India Novo Nordisk AS Full time

About the Role

We are seeking a highly skilled Pharmaceutical Compliance Leader to join our team at Novo Nordisk. As a key member of our Digital, Data & IT - Product Supply GBS unit, you will be responsible for ensuring compliance with current industry regulations, guidelines, and trends.

Key Responsibilities

  • Provide expertise in validation and ensure compliance with regulations, guidelines, and trends.
  • Support end-to-end audits and inspections, ensuring robust inspection readiness for GxP systems.
  • Drive continuous improvement in product quality and compliance systems.
  • Review and manage validation activities, including review, approval, and authorization of validation deliverables.
  • Lead timely quality system implementation and manage processes to ensure compliance and quality.

Requirements

  • Bachelor's degree in Electronics and Communication or relevant field.
  • 10+ years of experience in IT and relevant experience in Software Testing Lifecycle and Computer System Validation (CSV) across life sciences and healthcare domains.
  • Excellent communication skills to coordinate with stakeholders and ensure quality work.
  • Ability to represent Novo Nordisk in relations with users and external stakeholders.
  • Expertise in test delivery management, QMS, SQA activities, process assessments, testing activities, 21 CFR 11, 21 CFR 820 regulatory requirements, GxP compliance, and good documentation practices.
  • Strong focus on patient safety, product quality, validated state, and regulatory impact.

About Novo Nordisk

Novo Nordisk is a global healthcare company with a strong commitment to improving the lives of people with diabetes and other serious chronic conditions. We are dedicated to delivering innovative solutions that make a meaningful difference in the lives of our patients and customers.



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