Targovax is seeking an experienced Manager QA/ Senior Manager QA
14.09.2018 | AjankohtaistaTyöpaikkailmoitukset
Targovax: Activating the patient's immune system to fight cancer
Targovax is a clinical stage biotechnology company developing immune activators to target hard to treat solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine. Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect and replicate in cancer cells. It is used as a therapeutic cancer vaccine and has been shown to activate the immune system to generate tumor-specific immune responses. Targovax is also developing a neo-antigen cancer vaccine targeting tumors that express mutated forms of RAS. The TG vaccine program has shown a signal of efficacy in a 32-patient trial with TG01 in resected pancreatic cancer. Targovax has offices in both Oslo and Helsinki.
We seek dedicated, passionate and hardworking individuals who will bring their experiences, unique perspectives and problem-solving skills to our team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a difference in the lives of patients by working towards our mission: Activating the patient’s immune system to fight cancer.
Manager QA / Senior Manager QA
Targovax is seeking an experienced Manager QA/ Senior Manager QA to join our QA team. This position will support the design, implementation and maintenance of QA systems including, but not limited to SOPs, batch record review, training program, CAPA/deviations/change control, and perform internal and external audits.
The major responsibilities for this position are:
- Qualification of new and maintenance of existing suppliers of drug substance and drug product, including preparation of QA agreements, performance of audits and follow up of quality related incidents
- Adequate management of Deviations, CAPAs and changes
- To maintain and develop the Targovax Quality Assurance system
- To provide QA GXP (GMP, GLP and GCP) support where required
- To represent QA in development projects
- Secure compliance with applicable GXP
The position will require close cross-functional collaboration within Targovax. Collaboration with external partners as Contract Manufacturing Organizations and Service Providers will also be an important part of the work.
- Master of Science preferably Cand. Pharm. or another higher degree combined with relevant experience
- 5-10 years of experience within relevant QA positions in pharmaceutical industry.
- QA experience related to qualification, implementation and follow up of Contract Manufacturing Organizations
- Experience with establishment and improvement of Quality Assurance Systems
- Knowledge from working with EU and US GXP requirements in different stages of development
- Experience from working with GCP
- Ability to work independently and at the same time be a good team player
The position will also require excellent oral and written communication skills in English.
Travelling abroad will be required.
The position will be located either at Targovax’s office in Oslo, Norway or in Helsinki, Finland.
If you have any questions to the position, please contact:
Phone: +47 922 61 624
How to apply:
Please send in English your CV together with a one-page motivational letter on why you are suited for the position by 8 October 2018 to:
Phone: +47 922 61 624
To learn more about us, please visit: www.targovax.com