Qualified Person (QP)/Quality Assurance

Company
Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPS cells and hES cells and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden, and holds a Manufacturing license for the establishment of hES cell lines, hES cell banking and hiPS cell banking. The company is also expanding its operation into GMP-grade manufacturing of cell culture media. For more information, visit our website: www.takarabio.com
Description
Advanced Therapy Medicinal Products (ATMPs) is a new and promising area of therapeutics. The Qualified Person (QP) will be responsible for release of Good Manufacturing Practice (GMP) produced cell banks.
The Qualified Person will also be responsible for the Quality Management System governing all of Takara Bio Europe AB’s activities and needs to secure quality aspects throughout the company, extending to vendors, suppliers and consultants.
Strong organisational, leadership and team skills will be important to guide and align all stakeholders.
General tasks and responsibilities
· Serve as the Company’s Qualified Person.
· Review and release of GMP produced cell banks according to regulatory requirements and in accordance with the GMP manufacturing license.
· Maintain in-depth knowledge in Good Manufacturing Practice (GMP) and specifically GMP for ATMP clinical trial material.
· Maintain broad knowledge in Quality principles and theories.
· Lead and organise the maintenance and improvement of Takara Bio Europe’s GMP Quality system.
· Lead the implementation of the ISO9001 Quality Management System.
· Proactively identify and mitigate potential quality and safety risks.
· Provide guidance to colleagues on established company Quality policies and procedures.
· Provide guidance upon implementation of new procedures in accordance with GMP and regulatory expectations.
Specific tasks and responsibilities
• Overall handling of Takara Bio Europe AB’s Quality Management system
• Auditing
• Vendor qualification
• Risk Assessments
• Acting as host for regulatory inspections
• Serving as primary contact for the Swedish MPA for questions related to the GMP manufacturing license
• Providing the Tissue Establishment leader with regulatory advice when needed
Education Requirement (minimum)
· MSc in Pharmacy, Cell Biology or related field
Experience Requirement (minimum)
· Minimum of 5 years of experience in a GMP environment.
· Fulfill the requirements of a Qualified Person as detailed in EMA Eudralex volume 4, annex 16
· Experience from work as a Qualified Person named on a manufacturing license.
· Expert knowledge in GMP regulations (FDA/EU/ICH).
· Experience within biotechnology or biologics is essential and experience in the field of cell or gene therapy is considered an advantage.
· Strong knowledge in other Quality principles and concepts, in particular ISO 13485 or ISO 9001, is an advantage.
· Experience from work with contractors and suppliers, including hands on experience with external GMP audits


The Qualified Person can be placed at Takara Bio Europe’s site in Göteborg, Sweden, or elsewhere with regular travels to Göteborg.
The Qualified Person reports to the Site Head.
Submit your application no later than April 9, 2021. We apply continuous evaluation of applicants; therefore, this position can be filled before this due date.
For more information, please contact kristina_runeberg@takarabio.com
Phone +46 765 250 904