Quality Assurance Specialist

Nordic Nanovector's mission is to extend and improve the lives of patients with haematological cancers by developing and commercialising next-generation radio-immunotherapies. 
 
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 29 billion by 2026. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
 
Nordic Nanovector was established in Oslo in 2009 and is since March 2015 listed on the Oslo Stock Exchange.  

Quality Assurance Specialist 
(Biopharmaceutical industry)

 Nordic Nanovector is looking for a QA Specialist who will work on a commercial readiness project with one of our Contract Manufacturing Organisation (CMO) in Oslo, Norway. 
 
 
The QA Specialist will have the following key responsibilities:
 
* Support process regarding Quality performance monitoring (KPIs) and product quality review (PQR).
* Review and approve Specifications, protocols, reports, including validation, annual review and other quality documents.
* Ensure compliance to the Quality Agreements between the Sponsor and the CMOs.
* Perform supplier qualification including audits as requested and providing the associated documentation.
* Work closely with other cross-functional department
* Create and review quality documents and agreements
* Prepare and review quality documents including SOPs, deviations, change control, CAPAs, OOS's
* Ad hoc support to the QA organisation

 What are we looking for:

* Master's degree with experience in biotech/biopharma/pharmaceutical industry
* Minimum 3-5 years' of QA/CMC/GMP or RA experience. Preferably QA experience.
* Experience from a GMP regulated environment (production, QC or QA)
* Hands on role with the ability to work independently while embracing working in a team.
* Focus on prioritisation and getting tasks completed within agreed timelines
* Excellent communication skills, with a high proficiency in English written and spoken. Norwegian language is advantageous

Reporting line, location and compensation

The position reports to the Associate Director Quality Assurance and is based full-time at the CMO in Oslo, Norway. Nordic Nanovector offers a challenging and exciting role in one of Norway's most innovative pharmaceutical companies.
 
The position will be a temporary employment for 12 months and further employment thereafter would need to be discussed. We would like to fill this role as soon as possible and will consider applications for employment and contractor engagement.
 
Level of compensation will reflect experience and qualifications.
 
We take pride in our dedication to the company's mission to extend and improve the lives of patients with haematological cancers, and it is important that all members of our team are connected to this purpose.

 

How to apply:
Please send your CV together with a one-page motivational letter on why you are suited for the position to:
  
Annemieke Otten Nesse
Branch Manager Kelly Scientific Resources

Phone: +47 92 20 87 61