Sr GCP Advisor

Job Title: Senior GCP Advisor
Department Novo Nordisk Quality GBS
Novo Nordisk GBS Bangalore

Are you passionate about clinical quality Do you have an innovative mindset to drive change in a future-ready environment and support your colleagues and stakeholders by challenging the status-quo in a friendly and open-minded way If so there is a unique job opportunity waiting for you as our new Senior GCP (Good Clinical Practice) Advisor. At Novo Nordisk we will challenge you to do the best work of your life. Apply now and join a growing team working in an international environment.

The Position
As a Senior GCP Advisor your primary responsibility is to manage Content Control/Process Management processes for Clinical trials and ensure compliance to GCP regulations on behalf of the Process Quality Assurance (PQA). You will be serving as a GCP Advisor and be a member of the Clinical Trial (CT) SOP Council where you advice line of business regarding quality concerns ensuring quality mind-set. Your role also involves in providing support during GCP inspections. Your continuous focus on quality improvement would be an essential aspect of your job. You have been tasked with the following duties:

• Verify and approve Standard Operating procedures (SOPs) and right interpretation of GCP regulations as quality advisor
• Collaborate with Novo Nordisk Process Manager in a process group following Process Management guidelines.
• Regularly communicate with Process Quality Assurance Delegate (PQAD) to share insights
• Ensure maintenance of global CT SOPs and ensure compliance with internal & external requirements. Attend CT
• SOP council meetings and raise/present/discuss relevant quality concerns
• Capability to completely work independently leveraging robust GCP knowledge and being relevant with changing regulations and QMS needs
• Provide support to stakeholders in and outside R&D Quality during GCP inspections as applicable
• Ensure global consistency and compliance in clinical development process through process documentation information sharing and guidance. Be quality anchor for worldwide clinical development process

Qualifications
We are looking for a highly skilled and experienced professional with the following qualifications:

• Degree in medical/biological/pharmaceutical science or similar.
• Minimum of 10-12 years of experience within GCP other relevant requirements affecting the conduct of clinical trials and QMS.
• Pharmaceutical business and knowledge of GCP regulations and guidelines within drug development.
• Extensive experience in conducting clinical trials.
• Experience of overall QMS and quality processes.
• Experience with audits and inspection support.
• Thorough knowledge and understanding of the drug development and life cycle management processes preferably from participation in project teams.
• Global cross functional experience.
• Team player prepared to work in a dynamic international environment with tight deadlines.
• Ability to influence and set directions.
• Strong personal leadership skills and quality mindset.
• Display strategic -set with focus on optimising the way processes are handled in NN.
• Project management skills and ability to co-ordinate and facilitate globalised processes.
• Flexibility and team-oriented ready to re-prioritize and adapt to changes in continuously evolving environment.
• Ability to present complex quality issues in a global environment effectively.
• Work independently and lead with clear and confident decision making.
  Sound IT skills and demonstrate excellent presentation and communication skills.

About the department
R&D Quality is part of the Novo Nordisk Quality Organisation and plays a vital role in supporting the drug and device development process to ensure high quality as well as fit-for-purpose processes throughout the entire value chain. We at R&D Quality support LOBs with quality processes/systems and Quality Management Systems activities across Regulatory Affairs and Global Safety Clinical reporting and Clinical Data Sciences. We provide quality and compliance support to the organization being QAs for deviations SOPs change controls quality monitoring process reviews system validations and we are quality partners in transformational projects within Development & Research and Early Development areas. We work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society.

Working at Novo Nordisk
At Novo Nordisk we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes obesity and rare blood and endocrine diseases. From our labs to our factory floors we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas driving change with an unfailing belief that it can be done.

Contact
To submit your application please upload your CV online (click on Apply and follow the instructions).
Apply Now!

Deadline
1 March 2026.

Please note that we will invite for interviews on an ongoing basis and therefore encourage candidates to apply as fast as possible.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

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

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.