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.
Supply Chain Quality Manager TILLSATT
Company: Orexo AB

Postion: Supply Chain Quality Manager

Location: Orexo AB’s head quarter in Uppsala

Purpose of the role
As a Supply Chain Quality Manager you will be an integral part of Orexo’s corporate Quality & SHE unit and provide cross-functional and global quality and compliance expertise, support and leadership. You will work across the whole supply chain and all lifecycle phases of a drug product, from sourcing and procurement of starting materials or components, technology transfer and establishing external manufacture of drug products for clinical trials or for commercial distribution as well as manage the quality review and release of drug products for clinical trials and commercial distribution.

You will also assume ownership of certain global quality and compliance processes and as such accountable for leading the global application of these processes, monitor their effectiveness and efficiency, identify necessary corrective or preventive actions and drive the continual improvement.

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, quality control and/or quality assurance.
· Knowledge and skills in Quality Management and GxP requirements. Knowledge and skills in wider compliance management such as safety, health, environment, control substances, product security and/or ethical business practices is meritorious.
· Industry background from product or process development, technology transfer, production, quality control and/or quality assurance.
· Experiences in executing, coordinating and leading quality control, quality assurance and pharmaceutical starting material or product batch release processes, in development, launch and commercial phases, that relies on data and documentation generated by and provided from third parties, e.g. contract manufacturers/laboratories, packagers and/or distributors.
· Experiences in issues management, change management, technology transfer, batch review and batch release of pharmaceutical starting materials or products intended for human use, i.e. for commercial distribution or for use in clinical trials, in USA and preferably also in other regions (e.g. EU).
· Experiences in quality and compliance management and collaboration with external pharmaceutical companies, e.g. contract manufacturers/laboratories, packagers and/or distributors, pharmaceutical starting material suppliers or experiences within equivalent areas in such company providing pharmaceutical materials and/or services to external clients.
· Experiences in quality and compliance auditing, assessment and/or evaluation of external suppliers of pharmaceutical starting materials, contract manufacturers/laboratories.

Language skills
Great 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 Supply Chain Quality Manager, please contact Kristin Bolund, Recruitment consultant, PeakSearch.
Phone: +46 (0)70-386 89 69
E-mail: kristin.bolund@peaksearch.se