Orexo is a specialty pharmaceutical company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery technology. The company is commercializing its proprietary product, Zubsolv® sublingual tablets, for treatment of opioid dependence, in the US. The Zubsolv sublingual tablet is an advanced formulation of buprenorphine and naloxone using Orexo’s extensive knowledge in sublingual technologies. Orexo has a portfolio of two approved and revenue generating products currently marketed by partners under license in the US, EU and Japan.
Quality and Compliance Manager - TILLSATT
Company: Orexo AB

Postion: Quality & Compliance Manager

Location: Orexo AB’s head quarter in Uppsala

Purpose of the role
As a Quality & Compliance Manager you will be an integral part of Orexo’s corporate Quality & SHE unit and assume a pivotal role as global quality representative and quality management expert for Orexo’s processes for clinical development, pharmacovigilance and in-market event handling. You will also act as a process owner for certain such global and local processes owned by the corporate Quality & SHE unit.

The role reports to Orexo’s global Head of Quality & SHE and represent Orexo’s corporate Quality unit in all matters associated to clinical development, pharmacovigilance and in-market event handling towards Orexo’s US based Market Company, Orexo US, Inc (Morristown, NJ).

Orexo is a small growing specialty pharmaceutical company. The Quality & SHE unit work across the company and globally, why you in this role can get many areas of responsibility and have the possibility to grow and develop.

Qualifications
· University degree in relevant sciences, e.g. pharmacy, medicine, chemistry, biology or engineering (pharmaceutical, chemical or biotechnology).

General experiences:
· Solid experience within pharmaceutical industry from development, production, distribution, quality control and/or quality assurance.
· Broad experience from pharmaceutical industry, or other industry operating in such highly regulated environment (e.g. medical devices), including management of outsourced activities and procured services.
· Significant experiences from clinical development, pharmacovigilance, product distribution, quality control and/or quality assurance related to commercial and investigational pharmaceutical products or other such highly regulated products (e.g. medical devices).
· Experiences from e.g. line management, project management, process management and/or audit/inspection management, preferably in a global business environment and in relation to third parties.

Language skills
Excellent communication skills, in Swedish and English in written and oral.

Opportunities with the position
Orexo is in an exciting growing phase with possibly new affiliates and partners in Europe. The company strive to involve employees and give them individual ownership and responsibility. Orexo has an open climate and environment for employees, where new ideas and solutions is encouraged. Teams and department cooperate through the whole organization.

In this role you are involved in the whole chain, and have the possibility to influence with short decision paths. You can really make a difference! You work independently and has the authority to make decisions regarding your daily work as well as in your contact with external parties. You can always get increased responsibility as you grow in the role. In this position you have the opportunity to develop in many areas.

Contact
For more information about the position as Quality & Compliance Manager, please contact Kristin Bolund, Recruitment consultant, PeakSearch.
Phone: +46 (0)70-386 89 69
E-mail: kristin.bolund@peaksearch.se