Pharmaceutical Compliance Leader
1 month ago
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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