Derks & Derks
An interim position as Qualifed Person for a Biotech company in cellular immunotherapy
- an innovative, fast growing, biotechnology company
- a role where your knowlegde is welcome
- a permanent contract, starting with a 5 months contract
The organisation is a Biotechnology company focused on cellular Immunotherapy in clinical stages. Recently they develop a new method to make cancer a chronic disease and they can use some help. Our client is located in The Netherlands and has about 50 employees that think globally. They are ambitious and believe in their product. To expand their team they are looking for someone like them, always striving for the best. Currently they are looking for an Interim QP.
As Interim QP your role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role. The basic responsibility is to ensure that our cell and gene therapy products are manufactured and released according to quality guidelines, regulatory requirements and trial needs. You provide guidance and direction to Development, Production and Quality staff regarding compliance with quality standards and procedures.
You will be responsible for ensuring that each individual batch has been manufactured and tested in accordance with the requirements of the IMPD and the applicable GMP regulations. Also you are responsible for batch disposition (e.g. GMP-release) of the batches produced. You are involved in the set-up and validation of the manufacturing process, analytical methods and specifications. In addition to the QP role and responsibility the QP will help and assist with Document control, Deviation and CAPA system management but also Product complaints, returns, and recalls. Furthermore you give the Vendor approval, qualification and management and make round regarding the Internal (self-inspections) / external audit program. In this role you will report to the Chief Regulatory/Quality Officer with the obligatory dotted line into the CEO.
- Sc. or PhD degree in pharmacy, biotechnology, biology or equivalent
- experience in QP-related functions
- experience working in a GMP regulated environment
- experienced in biotech products where experience with Advanced Therapy Medicinal Products (ATMPs) is preferential
- knowledge of biotech production processes
- knowledge of sterile production processes
- knowledge of GMP quality systems
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-111-DD, to Sandra van Putten: firstname.lastname@example.org. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.