Arbetsbeskrivning

Associate Director Quality Assurance

Learn more about our company:

Takara Bio Europe provides innovative products for research, advanced therapy medicinal products (ATMPs) and the diagnostics market. As a member of the Takara Bio Group, Takara Bio Europe is part of a company that holds a leadership position in the global market and is committed to improving the human condition through biotechnology and to understanding and meeting the quality needs and expectations of all our customers.

At our state-of-the-art facility in Göteborg, Sweden, we provide production and testing capabilities for GMP-grade reagents as well as PCR enzymes for diagnostic applications.

For more information, visit our website: www.takarabio.com.

Takara Bio Europe Swedish Filial is seeking an Associate Director Quality Assurance to lead the quality assurance function. This includes responsibility for ensuring that the Quality Management System (QMS) is effective and maintained in accordance with applicable quality standards and current business activities. The company manufactures GMP-grade cell culture media for cell therapy applications, as well as enzymes and kits under ISO 13485 for research and diagnostic use. In addition, the company's operations and R&D activities are conducted under ISO 9001.

The Associate Director Quality Assurance is a member of the Takara Bio Europe Swedish Filial management team and serves as the quality representative.

The Associate Director Quality Assurance is responsible for establishing quality objectives, monitoring their achievement, and planning and conducting audits. The role is also responsible for maintaining the company's ISO 13485 and ISO 9001 certifications.

Core tasks / main responsibilities:

QMS

· QMS functional for the current business and its different quality standards incl GMP-grade

· Process to monitor QMS compliance, to secure quality aspects throughout the company, extending to vendors and suppliers.

· Appropriate QMS training of personnel in place

· Driving the management review process and internal audit process

Supply Chain for Manufacturing and Service

· Disposition of manufactured lots of Takara Bio Europe owned products

· Quality processes up to date and complied with

· Provide guidance upon implementation of new procedures in accordance with applicable standards and regulations including GMP or ISO standards.

· Proactively identify and mitigate potential quality risks.

Quality Assurance organisation

· Drive and distribute quality assurance tasks

· Ensure quality assurance personnel are appropriately trained

Authorities

· Disposition of products

· Issue CoA for released batches

· Approval of all QMS documents

· Approval of changes to eQMS

Skills and Qualifications:

University degree in Life Sciences.

Broad knowledge in quality principles and theories

In-depth knowledge in GMP preferably for ATMP

Knowledge in ISO13485 preferably for ancillary materials

Provide guidance to others in the quality field.