QA director
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology organization, based in Noord-Holland Netherlands.
They are engaged in the development of innovative cancer immunotherapies treatments. They focus on therapies designed to empower the immune system's ability to recognize and kill the cancer cells.
ROLE DESCRIPTION
Do you want to work as a highly motivated Director then join us. Do you want to be responsible in supporting the Quality team to find exciting new ways to improve cancer immunotherapy? Do you want to work cross functionally to develop our quality assurance systems and processes to meet all European requirements? Then this is the job for you!
RESPONSIBILITIES
As the quality assurance director you will be responsible for the QA team and be a part of the development and implementation of the quality systems. You will assist in disposition issue resolution related to manufacture and testing of vectors and the final products. Next to that you will be responsible for the following:
- performing QP site and laboratory qualification activities
- collaborate with the SQM and Supply Chain teams to improve supplier qualification and specification development processes
- Assure the key quality expectations
- provide leadership and direction for - SCARs, CAPAs, and Deviations
REQUIREMENTS
- Bsc or Msc degree in biotechnology or related field
- At least 10 years of experience in a pharmaceutical or biotechnological role.
- Previous experience managing and developing staff with a minimum of 6 years of experience.
- Experience auditing CMOs, CTLs and/or CROs.
- Experience writing, evaluating and closing investigations, CAPAs and change control records.
- In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Valentijn de Krom.
