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Senior GCP Advisor

14 - 17 years

16 - 19 Lacs

Bengaluru

Posted:2 months ago| Platform: Naukri logo

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Skills Required

GCP quality processes QMS Clinical Operations drug development Good Clinical Practice

Work Mode

Work from Office

Job Type

Full Time

Job Description

Department R&D Quality GBS Are you an expert in Good Clinical Practice (GCP) compliance? Do you thrive in a role where you can make a significant impact on quality and compliance processes? If so, we invite you to join our team as a Senior GCP Advisor. Read more and apply today for a life-changing career. The position As a Senior GCP Advisor at Novo Nordisk, you will: Serve as the subject matter expert on clinical supplier assessments, evaluating compliance with ICH/GCP and collaborating with Clinical Outsourcing Management to mitigate identified risks. Support stakeholders by ensuring quality and compliance oversight, promoting knowledge sharing both internally and externally to create a positive impact on processes and culture. Perform cross-functional data trend analysis to identify quality risks and share results with stakeholders globally. Review and approve action plans for global GCP audit findings, sharing knowledge with Clinical Operations for continuous improvement. Provide GCP training, assist in process improvement projects, support GCP audits/inspections with Health Authorities globally, and participate in relevant GCP working groups. Qualifications We are looking for a candidate who meets the following qualifications: Degree in medical/biological/pharmaceutical science or similar. 14+ years experience in GCP (Good Clinical Practice) and relevant clinical trial requirements is required. Through knowledge of GCP and guidelines/regulatory requirements within drug development and life cycle management processes Clinical vendor assessment experience Experience of overall QMS and quality processes Global cross functional experience is preferred Communicate complex information effectively and skilled in applying a risk-based mindset to quality aspects Flexible and team-oriented, with a strategic mindset focused on optimizing processes leveraging digital inclination.

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Pharmaceutical Manufacturing

Bagsværd Kalundborg

10001 Employees

202 Jobs

    Key People

  • Lars Fruergaard Jørgensen

    President and CEO

  • Jakob Riis

    Executive Vice President, Commercial Strategy & Corporate Affairs

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