Manager – CMC and Compliance Support (Quality Assurance)
|Main focus:||Quality Assurance|
The Quality Assurance department at HOOKIPA has an open Manager position for a QA allrounder with a special focus on CMC topics. As part of the growing department, the incumbent will act as point of contact for CMC related topics and represent QA in the respective subteams. Furthermore, the candidate will take over responsibility for operational tasks related to his/her role in close collaboration with other functions. In addition, the candidate will use his/her expertise to contribute to other tasks arising within the department in order to maintain GxP compliance. The ability to work in a fast-paced environment, professionalism, ability to work in a team as well as to respond quickly to evolving needs are all essential behaviors for this role. Implementation into day-to-day practice and constant evaluation of the applied processes will be tools for the Manager to help to continuously improve the established Quality Systems.
- Support project and CMC teams in decision making regarding aspects related to quality and/or compliance.
- Act as point of contact for other departments for CMC-related topics.
- Ensure compliance of development projects with applicable regulations and internal procedures.
- Take over responsibility and actively work on tasks related to the role (e.g. change controls)
- Support the QA department in maintaining GxP compliance.
- Actively contribute to other tasks within the department based on previous professional experience.
- Education in technical and natural/life sciences (university up to MSc)
- Profound experience in pharmaceutical industry in the field of Quality
- Experience with quality requirements and regulations regarding ATMP/GTMP
- Hands-on knowledge of EU and US GMP regulations
- Competence in Microsoft Office Tools
- Analytically skilled and problem-solving oriented
- Fluent in English, both spoken and written
What we offer
- Strong team with dedicated and passionate employees
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Working in a multinational and multicultural environment
- Help with shaping the Quality System of a growing biopharmaceutical company
Minimum monthly gross salary from EUR 3.857,-; depending on experience and qualification salary can be negotiated.
Starting date: as soon as possible