QA Sr. Manager
Location: NetherlandsAbout the company:
It is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. It is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs. We have build a state-of-the art manufacturing site in the Netherlands (Hoofddorp).
We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
Responsibilities (include but are not limited to):
- Perform selection audits, qualify and monitor compliance to qualification requirements.
- 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.
- Manage quality agreements with the ATC
- 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.
- Maintain the monitoring schedule and approved ATC list.
- Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
- 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.
- Ability to travel up to 50%
- Perform other duties as assigned
Requirements:
- Bachelor’s degree in Nursing, biological sciences, nursing, medical technologist or related field
- Proficiency in English written and verbal.
- Relevant experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems’ roles.
- Experience managing external suppliers, blood banks, and plasma centers.
- Medical center or pharmaceutical auditing experience preferred.
- Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.
- Previous experience in Quality Assurance, preferred.
- Proficient in MS Word, Excel, and Power Point
- Experience working in multicultural and cross functional teams
