Senior QA for Digital Partnerships (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 support the commercial organization for globally deployed digital health solutions and ensure compliant, safe and efficient integration of Novo Nordisk products with our digital health partner’s offerings. You will handle quality-related questions with Global Partners.
Furthermore, you will provide extensive quality support to the affiliates for locally driven partnerships.
You will work on one of the core processes in our department, Digital Health Partnerships, as we act as Process QA. In this role you will help optimize this process and the QMS to enable digital health business strategy while ensuring compliance throughout the entire digital health product lifecycle.
You will be based in mainly Søborg, near Copenhagen.

Some responsibilities include:

• Advising the relevant areas within Novo Nordisk on Quality Management System requirements and external regulations when engaging with external digital health partners.
• Providing input on designing and implementing compliant processes and procedures, to meet future business needs in Digital Health Partnerships e.g., launch of new product types and business models.
• Day-to-day support for expansion and maintenance of the Quality Agreements with global partners and the Quality Agreement template.
• Reviewing and approving corporate SOPs, ensuring implementation of applicable requirements and compliance signals, for both the Digital Health Partnerships.
• Participating and contributing to audits and inspections and further work on findings.
• Engaging with external partners and internal functions on a global level, such as Novo Nordisk affiliate companies around the world.
• Providing directions to process managers and stakeholders for ensuring compliance with applicable regulatory and internal requirements. Participating in the Process Reviews and identifying process improvements.

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.
• 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.