Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a Quality and Regulatory Director like you. For more information go to www.grifols.com
What your responsibilities will be
You will be the responsible person according to international and local laws for maintaining a Quality System based on applicable GxP principles of medicinal products.
You will have internal interaction with the affiliate staff, Commercial Operations Management and other teams of Commercial Division. External interaction with Distributors and Regulatory Authorities. Quality and Regulatory representative for Nordic, Baltic countries, Polonia and Belaruse.
- You will be nominated as the responsible person for GDP ensuring distribution activities to be in compliance with Good Distribution Practices of medicinal products. Elaborate and approve relevant SOP.
- You will be responsible of distribution activities (own or subcontracted) such as storage, shipping and transport, complaint management.
- You will be responsible to implement and maintain the Quality System of the affiliate being part of the digitalization process for this system.
- You will review the publicity messages and promotional material from a Regulatory perspective for the countries under his/her scope.
- You will be the responsible or local contact for pharmacovigilance and reactovigilance.
- You will obtain and keep updated all the licenses necessary for products and distribution activities.
- You will be the Regulatory Affairs local contact person with local authorities and Headquarters.
- You will act as the liaison with National Regulatory Authority of the country and neighboring countries.
- You will manage serialization activities related for the countries under his/her scope.
- You will manage the local batch release.
- You will be the Corporate Regulatory Affairs representative with the countries authorities under his/her scope.
- You will provide the medical information, to oversee the provision of accurate, relevant, timely information to internal and external customers in accordance with guidelines.
- You will be a team member of EU affiliates group.
Who you are
- Bachelor Degree in Pharmacy. Master in Pharmaceutical Industry would be a plus.
- Minimum 5 of years of experience in a similar position taking care of Quality and Regulatory Affairs matters in the territories. Experience in Quality System based on ISO 9001 is preferred.
- High Level of English and Swedish.
- High profile role that demands an experienced professional with strong management skills. Understanding of financial terms and principles. Ability to analyze complex data and develop innovative solutions. Translate ideas into deliverables. Make informed decisions when presented with conflicting information and opinions.
What we offer
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available here. If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!
We look forward to receiving your application!
Grifols is an equal opportunity employer.
You will be located in Stockholm city.
In this recruitment Grifols collaborates with Experis. Interviews are held ongoing, so do not wait to submit your application. For questions regarding the position, please contact Recruitment consultant Rutger Carlheim-Gyllenskiöld at 070-377 53 52, Rutger.Carlheim-Gyllenskiold@se.experis.com or Håkan Kempel 073-021 18 33, firstname.lastname@example.org .
Contract of Employment: Permanent position