Digital Health Senior Quality Specialist (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Quality

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Are you passionate about quality, business understanding and communication with many stakeholders across the company? Do you want to shape the future of your area? If so, this is a unique opportunity, where you will be responsible for a broad area with many diverse stakeholders - apply now!

The position
You will lead the Quality agenda to support Novo Nordisk's digital health business strategy, ensuring that the NN QMS is prepared and reliable for launching compliant solutions by incorporating the necessary regulatory requirements. You will be highly involved with analyzing compliance signals and guide on how to turn those into concreate actions e.g. update of QMS or Standard Operating Procedures (SOPs).
You will engage in a broad stakeholder landscape as part of a Digital Health Focus group set-up in NN. Here you will collaborate and share knowledge across the Digital Health QA’s both inside and outside of the department.
You will be based in Søborg near Copenhagen.

Some responsibilities include:

• Set the Quality direction within the commercial strategic initiatives for Digital Health. Providing directions to process managers and stakeholders for ensuring compliance with applicable regulatory and internal requirements.
• Provide guidance on the Quality Management system within Novo Nordisk, to ensure that Digital Health is reflected.
• Support Affiliates with communication, training, and expert knowledge on Digital Health offerings.
• Act as the compliance signals expert, analyzing and guiding the Digital Health regulatory environment. Identify and document process impacts, offering input on developing compliant processes to meet future business needs in Digital Health.
• Oversee Quality processes by reviewing and approving corporate SOPs, ensuring implementation of Requirements & Compliance signals, participating in audits, process reviews, identifying and driving Quality management reviews.

Qualifications
The position requires efficient collaboration and communication with stakeholders from across Novo Nordisk. To succeed in this role, you need:

• A Master's degree within Pharmacy, Engineering, Management or similar.
• Extensive Quality Assurance knowledge and experience from the pharmaceutical industry or other regulated areas.
• Knowledge of GxP requirements and/or ISO9000 and ISO13485 (is an advantage).
• Great communication and stakeholder management skills.
• Excellent command of English.

On a personal level, you have the ability and experience to influence and set direction. You have a quality mindset and eye for detail. Flexibility is key to re-prioritize and adapt to change. You are passionate about process improvements and finding solutions to complex challenges.

About the department
Digital Health & Staffs Quality consists of a group of engaged and motivated QA Specialists and Project Managers. The department serves as the competence center for digital health quality and compliance, offering support for customer-facing software solutions, including health software, SaMD as a Service, and digital health partnership ecosystems. We ensure consistent quality throughout the lifecycle of these solutions, ensuring adherence to applicable requirements and upholding the Quality Management System (QMS) to ensure reliability for patients and HCPs.
Additionally, we are QA-responsible for Novo Nordisk processes within Customer Complaints, Customer Service, and other Staffs areas. We have the QA oversight for these processes and lead various strategic global projects and initiatives within Quality.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. 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, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact
For any questions, please reach out to the Director of Digital Health & Staffs Quality, Katrine Augustinussen, +45 30 79 07 32.

Deadline
22 September 2024.
Please note that interviews will be conducted on an ongoing basis as relevant applications are received, so we encourage you to apply as soon as possible.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV.

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.