Nettside Hubro Therapeutics
Hubro Therapeutics AS is a clinical stage private Norwegian biotech company founded in 2018 and located in Oslo. Our focus is on development of novel proprietary anti-cancer vaccines. We believe that cancer vaccines will play important roles for the further improvement of immunotherapy of cancer. It is our desire and sincere hope to improve the lives of cancer patients. Our lead candidate peptide vaccine in clinical development is FMPV-1. FMPV-1 targets frameshift mutation in the transforming growth factor β receptor 2 (TGFβR2) gene, frequently present in MSI-colorectal, stomach cancer as well as in hereditary colorectal cancer. We have two new vaccine candidates in our pipeline ready for the initiation of clinical development. More info at www.hubrotherapeutics.com
QA Manager / QA Sr Manager
Come and join one of the most exciting, dynamic, and fast-growing peptide vaccine biotech companies in Norway!
Hubro Therapeutics is currently seeking an experienced QA Manager/ QA Senior Manager who will take an active role in QA activities to further development of our products and the company.
This position offers an opportunity to work with a competent and dedicated Hubro team developing novel cancer vaccine treatments. You will have varied and challenging responsibilities in an innovative and dynamic work environment. We promise you will develop your personal skills through continuous learning in close collaboration with nice colleagues and CROs/CDMOs.
Main Responsibilities:
- Provide quality assurance expertise for Hubro clinical trial and drug development programs during preclinical and clinical phases.
- Ensure compliance with EU and US GxP (GMP, GCP, GCLP, GDP etc)
- play an active role in further development and maintenance of the Quality Management System to support the clinical program and product development activities within CMC, preclinical, clinical, and regulatory.
- Ensure QA oversight and qualification of Service Providers, including Contract Manufacturing Organizations, Contract Research Organisations, Clinical laboratories.
- Perform and/or manage internal and external audits
- Prepare and update Quality Agreements with CMOs
- Handling of deviations/CAPA, change control
Skills & Competencies:
- MSc preferably in pharmacy, or another higher degree combined with relevant experience.
- Solid experience and knowledge of GMP, GDP, GCP and GCLP quality standards for clinical development phases.
- Experience from QA work in pharmaceutical or biotech industry and R&D
- Experience with establishment and improvement of Quality Management System
- Strong interpersonal skills with the ability to build trustful relationships
- Ability to work independently and at the same time be a good team player
- Strong English communication skills
Additional info:
The position will be based at Hubro Therapeutic´s main offices at Oslo Cancer Cluster incubator in Oslo, Norway. Some international travel and participation / presentation at science conferences and events can be expected. English is our working language.
The position reports to Tina Madsen, Chief QA Officer.
Contact information:
The recruitment process is carried out in collaboration with the consulting company Borka Consulting AS.
If you have any questions regarding Hubro Therapeutics or the position, feel free to contact our recruitment advisor in Borka Consulting; André Borka at +47 908 31 871 or email to andre@borka.no
Please send your application (both motivational letter and CV in PDF format) to andre@borka.no
All inquiries are treated confidentially, also towards Hubro Therapeutics in the initial phase if desired.
We look forward to receiving your application!
NOTE: Unfortunately, we sometimes experience that applicants do not receive a reply to an email from us, in which case our reply has most likely ended up in the spam filter on your mail server. Please check this if you miss answers from us, we always answer!
Borka Consulting is a specialised search & recruitment company that has 100% focus on competence-based search and recruitment in the Life Sciences sector.
