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 Cellular Therapies (f/m/d)

(Reference No. OP2107)

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Responsibilities

  • Collaborate with the Technical Development and Manufacturing Teams in their interaction with external partners in all Quality related aspects
  • Be the contact person for support of quality issues in Technical Development and Manufacturing
  • Review and approve GMP and regulatory (Quality Module) controlled documentation along the entire manufacturing process
  • Arrange and prepare QP releases including review and compilation of documentation required
  • Perform qualification/technical visits at vendor sites in order to support the appropriate vendor selection and supplier qualification
  • Organize, conduct and document audits at vendors, service providers and collaboration partners including follow-up (CAPA management)
  • Establish, review and maintain Quality- and Technical Agreements
  • Quality representative in cross-functional Program Teams (XPTs)
  • Pro-active contribution to the development, the continuous improvement and the maintenance of the Quality Management System
  • Ensure quality processes are established and conducted in accordance with guidelines, all relevant regulations and Affimed processes
  • Organize and conduct GXP trainings (e.g. SOPs)
  • Prepare and conduct self-inspections and report results within Affimed including follow-up
  • Organize, follow-up, and participate authority inspections

Requirements

  • Bachelor/Master Degree
  • At least eight years experience in Quality and/or GxP regulated environment
  • At least five years experience with the development of cellular therapeutics
  • Know-How of scientific and technical correlations
  • Independent, well-structured and goal- and solution oriented working behaviour
  • Excellent knowledge of national and international regulations applicable for ATMPs and cellular products
  • Excellent knowledge of national and international regulations and guidelines applicable for the pharmaceutical industry especially with regard to GMP
  • Experience in interacting with authorities (German authorities, FDA)
  • Experience in auditing vendors
  • Ability and experience working in cross-functional teams and in a matrix organization
  • Strong team player supporting and guiding teams
  • Strong leadership and communication skills
  • Critical thinking and complex decision making
  • Resilience and tenacious drive
  • Flexible, proactive, interactive
  • Ability to influence
  • Willingness to travel
  • Fluent in oral and written English, additional German language skills would be a plus

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).

July 2021

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