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Digital Health Quality Strategist
2 months ago
About the Role
We are seeking a highly skilled and experienced Digital Health Quality Strategist to join our team at Novo Nordisk. As a key member of our Digital Health & Staffs Quality department, you will play a critical role in shaping the future of our digital health business strategy.
Key Responsibilities
- 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.
- Analyze compliance signals and guide on how to turn those into concrete actions, such as updating the QMS or Standard Operating Procedures (SOPs).
- Engage with a broad stakeholder landscape as part of a Digital Health Focus group set-up in NN, collaborating and sharing knowledge across the Digital Health QA's both inside and outside of the department.
- 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, identifying and documenting process impacts, and 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.
Requirements
- 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.
About the Department
The Digital Health & Staffs Quality 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.
Working at Novo Nordisk
We are 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.
