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Associate Director, Qualified Person - EU Amsterdam Netherlands,
Job Score (company)
Posted on : 03 August 2017
- Our company is a bio pharmaceutical 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 recognise and kill tumours.
- our company 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 are seeking a highly motivated individual to join us as a Qualified Person located at our the Netherlands company location.
- You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
- This individual will work cross functionally to develop our quality assurance systems and processes to meet all European requirements.
- This role will be a hands-on resource reporting to the company quality assurance head.
Responsibilities (include but are not limited to):
- Responsible for working with the company quality team
- Develop and implement company Qualified Person (QP) process for product disposition within the EU member countries (per EU Directives 2001/20/EC and 2001/83/EC.
- Disposition issue resolution related to manufacturing and testing of vectors and final product from US and European sites to EU destination.
- Support site QA head in the implementation of Supplier Quality oversight program in EU. QP must be involved in all critical suppliers, including contract manufacturers and contract test laboratories as well as treatment centers.
- Ensure that the marketing Authorization and Manufacturing Authorization or IMP Authorization requirements for the products have been met for the patient batch concerned.
- Support site QA head in setting up a robust Quality Management System for our company in EU, meeting EU standards, in line with and leveraging from the company US QMS. The objective is to obtain a GMP license for the company EU activities for its GMP activities.
- Review all submissions (CMC) to regulatory authorities concerning the product (IMP/MP).
- Build relationships with all other functional teams within the company, particularly with the QPPV in EU (and counterpart in US) to ensure smooth implementation and maintenance of the Pharmacovigilance system in EU (Eudralex volume 9b).
- Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
- Ability to travel up to 25%.
- Perform other duties as assigned.
Knowledge, Experience & Skills
- Registered QP in The Netherlands, experienced in the disposition of biologic products for clinical and commercial use, preferably ATMP s.
- Bachelor s degree in biological sciences or related field and extensive experience in a pharmaceutical or biologics role. An advanced degree is desirable.
- Experience auditing CMOs, Contract testing labs and/or CROs.
- Experience with direct European Health authority inspections and interactions
- 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
- Proficient in MS Word, Excel, and Power Point
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Must be able to work on multiple projects simultaneously and demonstrate organisational, prioritisation, and time management proficiencies
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
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