Senior GCP Advisor

1 week ago

Bengaluru, Karnataka, India Novo Nordisk Full time

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 processesClinical vendor assessment experienceExperience of overall QMS and quality processesGlobal cross functional experience is preferredCommunicate complex information effectively and skilled in applying a risk-based mindset to quality aspectsFlexible and team-oriented, with a strategic mindset focused on optimizing processes leveraging digital inclination.

About the department
R&D Quality is an integral part of the Development Organisation, playing a vital role in supporting the drug and device development process to ensure high quality and fit-for-purpose processes throughout the entire value chain. Based in a global setting, we focus on delivering viable products that make a difference to patients and ultimately benefit society. Our team supports LOBs with quality processes/systems and Quality Management Systems activities across Regulatory Affairs, Global Safety, Clinical reporting GBS, and Clinical Data Sciences GBS. We are quality partners in transformational projects within Development & Research and Early Development areas.
 

Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-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 63,000 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.
 

Contact 
If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.
 

Deadline 
Apply on or before: 21st March 2025.

Disclaimer 
It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

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