GCP Advisor

4 weeks ago

Bengaluru, India Novo Nordisk Full time

The position

As a GCP Advisor at Novo Nordisk, you will: Act as a quality anchor, facilitating knowledge sharing, ensuring compliance, and fostering a positive organizational culture in GCP. Review, comment on, and QA approve Clinical Deviation & Change Controls/CRs, Perform cross functional data trending on quality signals Take on CAPA QA Responsibilities Qualifications To be successful in this role, we are looking for a candidate with the following qualifications: Academic degree in medical/biological/ pharmaceutical science or similar. Minimum of 10-12 years of experience in GCP, with a deep understanding of relevant requirements impacting clinical trial conduct and Quality Management Systems (QMS). Proficiency in clinical vendor assessment. Comprehensive knowledge of GCP and drug development guidelines. Experience in managing overall QMS and quality processes Global cross functional experience is preferred About the department The R&D Quality department is a vital part of the Development Organisation at Novo Nordisk. We play a crucial role in supporting the drug and device development process to ensure high quality and fit-for-purpose processes throughout the entire value chain. Our team provides quality and compliance support to various areas within the organization, including Regulatory Affairs, Global Safety, Clinical reporting GBS, and Clinical Data Sciences GBS. We work in a global setting, focusing on delivering viable products that make a difference to patients and benefit society. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a -year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63, employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us Together, we go further. Together, we’re life changing.

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