Quality Manager Denmark, Norway and Sweden
This exciting and challenging role poses a unique opportunity to be part of a great cross-border collaboration across Scandinavia.
As our Quality Manager, you will work close with our business, give support in Quality & Compliance, and support the organization throughout the value chain. You will report to the Head of Quality Norway, Sweden and Denmark the risks you have identified within the Countries and work with the business towards the mitigation of these risks. The main purpose of the job is to drive demand for Quality-process like:
- Maintain the existing ISO 9001:2015 certification and all mandatory elements as required
- Conduct, lead and follow up via Internal and External Audits (at Suppliers) as Lead Auditor
- Support and collaborate with other countries with your expertise and work in Q-projects mainly across Scandinavia and some other (European) countries
- Implementation of Regional Operating Procedures and cooperation with internal stakeholder from the business like (but limited to :) Quality Centre of Excellence (QCE), Human Resources
- Implementation of Roche Diagnostics and Diabetes Care standards in the organization
- Monitoring performance metrics (Quality-KPIs) and reporting to the top management as needed and advised by Head of Quality Norway, Sweden and Denmark
- Maintenance of internal electronic tools to support and maintain Quality Processes
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
This position will require travelling, why it is important that this is something that you would enjoy and that would suit your daily life today.
BA/BS, MS degree and/or PhD in Life Sciences, Medical or engineering field.
Minimum 5-7 years’ experience from work in a Quality related Field (such as but not exclusively limited to: Quality Management, Assurance or Quality Control). B.Sc. or equivalent and minimum experience 5-7 years in QMS management (in Diagnostics/Healthcare/Pharma business).
- You have an understanding of the Scandinavian health care system
- In deep understanding of ISO 9001:2015, being the Subject Matter Expert in all of its Elements
- Strong diplomatic skills in negotiation and conveying messages and selling mandatory requirements to stakeholders, but also the ability to communicate data and messages in a clear and concise fashion
- Strong knowledge in the Microsoft Office Package, SAP would be an advantage
- Understanding of ISO 13485, ISO 19011, ISO 27001, IVDR/MDR, CSV, GMP or 21 CFR 820/803/807 is an advantage
- Strong presentation and communications skills in both a Scandinavian Language (Swedish or Norwegian or Danish) and English is a must
- Experience as an Auditor is an advantage
- You are very independent in your work and like taking initiative. It is also important that you are a team player that likes to contribute to the group and work towards common goals
- You are a genuine problem solver and an extrovert person who enjoys having many contacts in your daily work
- Open minded with an eagerness to innovate, learn and change.
- Your focus is to create value for your customers and to deliver results
- You like building new relationships in your daily work. You enjoy, and feel comfortable, having discussion beyond country borders and cultures.
Who we are
At Roche, 91,700 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Interviews for this position will commence immediately. If there are any questions regarding content or the position itself, please reach out to the potential hiring manager Klaus.Geissler@roche.com. Looking forward to your application.
Roche ist ein Arbeitgeber, bei dem Chancengleichheit zählt.Quality, Quality > Quality Assurance