ePID Quality Manager in Global Development
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Søborg
- General Management and Administration
- Søborg
Are you ready to co-drive the digital transformation of Global Development? We are on a journey towards leveraging various digital opportunities to support the business including better use of our data and automating processes. Are you hungry to make clinical trial participation easier and more engaging for participants?
The electronic Patient Interaction Device (ePID) Product is an industry leading e-device solution for connecting patients, HCPs and Novo Nordisk during clinical trial execution. The ePID Product is a new digital product in development and will enter production in 2020. We are looking for an ePID Quality Manager to be an integral part of the ePID Product’s development and its continuous fit-for-purpose deployment across clinical trials.
About the department
You will become part of our ePID Product Management department belonging to Global Development and located in Søborg, Denmark.
The ePID Product Management team brings together the ePID Product Owner, Solution Specialist, Risk Manager, Scrum Master, UX/UI, Software Developer and Service Operations Manager roles. The team is responsible for the development and maintenance of the ePID Product, including fit-for-purpose configuration of the ePID Product for use in clinical trials.
The ePID Product Management team is an effective in-house software development team working to Agile principles and values.
The position
As Quality Manager your role is to understand every aspect of the ePID Product solution so that you can design, monitor and manage team compliance with the ePID Product’s system lifecycle processes. In this role, you are ‘hands-on’, enjoying the benefits from this.
The role includes ownership, authoring and revision of the end-to-end system lifecycle processes e.g. from Strategy People Software development Operations Issue triage Change management Retirement.
It is important that the ePID Product’s quality objectives are universally understood across the ePID team. It is equally important that processes remain fit-for-purpose, adjusting as needed to ensure an optimal balance between control process/compliance with agility of development. There is a training element to the role as well as the promotion of a fit-for-purpose quality focused culture within the team. Patient safety, security, privacy and data integrity will always be at the forefront of your mind.
You will quickly discover that the ePID Product exists in a unique quality space, needing to utilise quality elements, principles and best practices from across the IT, Medical Device and GCP quality spaces. To bridge existing gaps, in the short-term you will own the ePID Quality Implementation Plan. Over the medium-long term you will work with QMS authors to align NN’s formal QMS for in-house software development, operations and retirement, striving for one QMS wherever possible.
In the role you will be considered the Quality expert both within the ePID team, but also when interfacing with other adjacent teams pursuing similar objectives. You will be a reviewer/approver of relevant ePID documents and activities prescribed by the system lifecycle processes. In the role you will support the Quality Assurance representative’s understanding of the ePID Product and trial-level configurations as well as building in any evolving needs into the ePID system lifecycle processes.
The role requires a considerable amount of self-drive/direction setting and accountability. The ePID Product and team can be considered a ‘start-up’ style environment and therefore your role is expected to evolve and mature as the ePID Product platform matures.
You will not only learn about an industry leading digital product, you will also quickly learn and shape how cutting-edge software development and new agile ways of working are executed in practice!
Qualifications
We are looking for a candidate with experience from one or more business areas in global clinical drug development. The ideal candidate will have:
• Minimum 5-year experience within clinical projects and/or IT projects using clinical trial tools.
• Experience in a Quality Assurance role is an advantage
• Project leadership experience within an expert role requiring a high level of collaboration across skill types.
• Extensive interest and experience working with clinical trial connected devices and/or software apps is a must.
• Strong knowledge of and experience with clinical IT tools
• Leading in business knowledge: IT Industry, Regulatory GCP, Business Process Understanding
• Strong knowledge within good documentation practice and compliance
• Knowledge of verification and validation activities
• Experience from cross-organisational work driving business critical initiatives
• Solid understanding of the global Novo Nordisk development organisation and QMS landscape
We emphasize accountability and reaching goals through a collaborative effort, thus it is essential that you can use your good interpersonal and communication skills to achieve results together with others. You enjoy responsibility and complete your assignments proactively and within deadlines. Finally, you can communicate fluently in English, both in speech and writing.
Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and to benefit from a range of possibilities for professional and personal development.
Contact
For further information, please contact Roland Foster +45 3075 2817.
Deadline
14 August 2020
Please note that applications will be reviewed on a rolling basis and interviews held as soon as suitable candidates are identified.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 13.7.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Afdelingsleder
- Søborg
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