Key Responsibilities
Quality Management Systems and general QA Responsibilities
- Pro-active contribution to the development, the continuous improvement and the maintenance of the Quality Management System of Affimed
- Ensuring quality processes are established and conducted in accordance with guidelines, all relevant regulations and Affimed processes
- Organization and conduct of GMP-related trainings (e.g. SOPs)
- Preparation, conduct of self-inspections and reporting of results within Affimed including follow-up
- Organization, Follow-up, and participation of authority inspections
Operational Quality Assurance and Quality Control Responsibilities
- Collaborating with the technical development teams in their interaction with external partners in all Quality related aspects
- Contact person for support of GMP issues in technical development and manufacturing
- Review and approval of GMP and regulatory (Quality Module) controlled documentation along the entire manufacturing process
- Arranging and preparation of QP releases including review and compilation of documentation required
Third Party Quality Assurance Responsibilities
- Performance of qualification/technical visits at vendor sites in order to support the appropriate vendor selection and supplier qualification
- Organisation, conduct and documentation of audits at vendors, service providers and collaboration partners including follow-up (CAPA management)
- Establishing, review and maintenance of Quality- and Technical Agreements
Matrix Organization Responsibilities
- Representing Quality function in cross-functional Program Teams (XPTs) for supporting program progress
Required Qualifications:
- Bachelor / Master degree in Natural Sciences
- Thorough understanding of national and international laws, regulations and guidelines regarding GMP
- Experience in interacting with authorities (German authorities, FDA)
- Broad experience in Quality Management, including the development, establishment and maintenance of quality systems
- Strong resolve and steadfastness in upholding quality standards at external partners as well as internally
- Ability and experience to work in a cross-functional team and an international environment
- Experience in auditing vendors
- Strong team player and collaborative mindset
- Professional working proficiency in German and English, with excellent oral and written communication skills
- Proficient user of MS Office applications
Opportunity
The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary and collegial team.
For any queries, please contact Susanne Hering (Tel: 06221 6743 675, e-mail: s.hering@affimed.com).
February 2020
