Manager QA / Senior Manager QA
- Arbeidsgiver
- Targovax ASA
- Stillingstittel
- Manager QA / Senior Manager QA
- Frist
- 08.10.2018
- Ansettelsesform
- Fast
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.
Job qualifications
- 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.
Om arbeidsgiveren
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.
- Sektor
- Privat
- Sted
- Lilleakerveien 2c, 0283 Oslo
- Bransje
- Farmasi og legemiddel
- Stillingsfunksjon
- Helsepersonell / Farmasøyt,
- Dokumentasjon,
- Kvalitetssikring
Nøkkelord
Quality Assurance
Spørsmål om stillingen
- Kontaktperson
- Renate Birkeli
- Stillingstittel
- HR
- Mobil
- Vis telefonnummer
Lilleakerveien 2c, 0283 Oslo