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Digital Health Senior Quality Specialist
2 months ago
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:
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.
