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Clinical Quality & Training Manager

Category:  Quality
Location: 

Gatwick, West Sussex, GB

   

Would you like to be part of our UK Clinical Development Centre leadership team as we set out on a journey into new and exciting therapeutic areas and ways of working?

 

Can you help us bring new treatments to patients, faster and smarter by leading and optimizing clinical quality and training? Then you could be our new Clinical Quality & Training Manager!

 

The Job
You will have overall accountability for clinical quality and training for the UK Clinical Development Centre (CDC). 


This will involve leading the strategy, planning and implementation of the Quality Management System (QMS) and training of staff for CDC UK to ensure compliance with procedures and legislation relating to clinical trials and Good Clinical Practice and is inspection ready at all times. 


You will support the UK CDC team with assessment of potential or actual issues pertaining to GCP and development of CAPAs. You will be the principal local point of contact in the event of a Regulatory GCP inspection, working closely with R&D quality and inspection functions.


You will support a culture of quality risk management, identifying process improvements and communicating relevant quality topics to the department. 

 

Qualifications
Educated to degree level in Life Sciences, or equivalent, preferably holding a post-graduate certificate. 


You will have proven experience in clinical operations and /or in a clinical compliance or quality function. This could be gained within a UK (or similar) clinical research environment, or in a regional or global role. 


With a passion for training and coaching employees, you will bring to us your experience of Risk Based Quality Mindset and associated training techniques, together with your quality assurance/auditing experience and full understanding of UK/Europe clinical trial regulations.


You will be able to demonstrate your knowledge of the clinical trials environment - ICH GCP, regulatory issues, SOP’s - with experience of internal GCP audits and preferably Regulatory Authority inspections and as a GCP auditor. 


About the department
The UK Clinical Research team of approximately 75 employees is part of the UK Clinical, Medical and Regulatory (CMR) department with responsibility for running all global development clinical trials in the UK. The team has trial management and administration functions based in the UK Gatwick office and three field based CRA teams to cover the monitoring of clinical trial sites across the country. 


Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, stiving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.


 What we offer?
We offer a competitive salary plus bonus, private healthcare, life assurance, income protection and a fantastic pension scheme. You will also be entitled to flexible benefits which include holiday insurance, childcare vouchers, optical insurance, holiday buy and sell, Perkbox and much more! Working at the head office at Gatwick you also have access to even more amazing benefits such as free parking, free breakfast and lunch, lunch time fitness classes, access to our gym and workplace massages! 


Novo Nordisk offers an excellent inclusive culture with a focus on healthy living, flexible working and corporate social responsibility activities. The Novo Nordisk Way includes our vision, our values and our commitment to ensure we are a great place to work and we want you to be a part of that!

 

Contact

Please apply via our careers site. We are not able to accept direct CVs.

 

Deadline
8th December 2021


 

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.