Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company which engineers targeted immunotherapies, seeking to improve patient outcomes through the power of innate immunity. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. We are developing single and combination therapies to treat cancers.

To strengthen our highly motivated Operations-Team in Heidelberg, Germany, we are looking for a full-time

Quality Manager GMP (f/m/d)

(Reference No. OP2012)

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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).

November 2020

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