Job Description

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Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...Category\xc3\x97Select how often (in days) to receive an alert:\xc3\x97Select how often (in days) to receive an alert:Senior GCP AdvisorCategory: QualityLocation:Bangalore, Karnataka, INDepartment - R&D Quality GBSAre 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 PositionAs 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

• 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 departmentR&D Quality is part of the Development 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 NordiskAt 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.ContactTo submit your application, please upload your CV online (click on Apply and follow the instructions).Apply Now!Deadline29th March 2024.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.

Novo Nordisk