Sr QA Specialist
Location: Amsterdam area
Duration: one year (with possible extension)
Language: English and German
Note: Can work fully remotely - does not need to relocate to NL. Due to 50% travel in mostly EU, European passport holder preferred
Our client is one of the leading companies in the development of innovative cancer immunotherapies. Their focus is on cell therapy, using genetically modified immune cells programmed to target tumors. In what they believe has the potential to change the way cancer is treated.
Hence, they are looking for a highly motivated individual with medical or Pharma industry experience to work on innovative T cell therapy for cancer treatment. As a Sr QA Specialist your main focus will be on new site qualification for apheresis in hospitals - this work has DIRECT impact on being able to treat more patients! The position is part of the European Product Distribution and Quality team.
Your primary accountabilities:
- Assist in the management of an apheresis and treatment center (ATC) qualification process that will use risk-based tools for qualification, training, monitoring and disqualification.
- Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
- Perform selection audits, qualify and monitor compliance to qualification requirements.
- Assess and approve any changes to apheresis collection module, cell order tracking and order processing systems to assure validated state of the systems is maintained
- Assist in development, implementation and management of ATC management system (Oracle Agile)
- Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
Qualifications & Skills
- Minimum Bachelor’s degree in Nursing, biological sciences, medical technologist or related field
- At least 8+years of Quality experience, can be GLP/GMP/GXP/Regulated or Medical Devices or pharmaceutical environment, including nursing or blood banks or vaccines or biologics quality systems’ roles.
- Experience managing external suppliers, blood banks, and plasma centres.
- Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centres or pharmaceutical auditing preferred.
- Proficient in MS Word, Excel, and Power Point
- Proficiency in English and must speak business level German essential in a collaborative work environment
- Ability to travel up to 50% in mostly EU, European passport holder preferred
For this role an EU passport or (search year) VISA for Europe is required. No Intercontinental sponsorship possible. Are you ready to take a new step in your career? If you are interested or have any questions, Please reach out to me by applying to this vacancy