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

Senior Quality Manager GMP (f/m/d)

(Reference No. OP2012)

Apply now

Key Responsibilities

  • Operational Quality Assurance Responsibilities

    • Collaborate with the Technical Development & Manufacturing teams in their interaction with external partners in all Quality related aspects
    • Monitor and assess compliance GMP issues
    • 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
  • Third Party Quality Assurance Responsibilities

    • ­Provide quality oversight of CDMOs including:
    • Support the appropriate vendor selection and supplier qualification
    • Organize, conduct and document audits at vendors, service providers and collaboration partners including follow-up
    • ­Establish, review and maintain Quality- and Technical Agreements
  • Matrix Organization Responsibilities

    • ­Quality representative in cross-functional Program Teams (XPTs)
  • Quality Management Systems and general QA responsibilities

    • Pro-active contribution to the development, the continuous improvement, and the maintenance of the Quality Management System, especially with regard to GMP requirements
    • Ensure quality processes are established and conducted in accordance with guidelines, all relevant regulations and Affimed processes
    • Organize and conduct GMP-related trainings
    • Prepare and conduct self-inspections and reporting results within Affimed including follow-ups
    • Organization, Follow-up, and participation of authority inspections
  • Providing guidance and direction to Quality Managers GMP ­ – Prioritize and distribute work packages within the team
    • Train and develop team members

Required Qualifications:

  • Bachelor/Master degree in Scientific or Technical field (e.g. Pharmacist, Chemist, Biologist)
  • Know-How of scientific and technical correlations
  • Independent, well-structured and goal- and solution oriented working behaviour
  • 8 -10 years of Quality Assurance GMP compliance experience in the biopharmaceutical industry
  • Excellent knowledge of national and international regulations and guidelines applicable for the pharmaceutical industry especially with regard to GMP
  • Experience in interacting with authorities (EMA, FDA)
  • Experience in supporting inspection readiness activities
  • Experience in auditing vendors
  • Ability and experience working in cross-functional teams and in a matrix organization
  • Strong team player supporting and guiding teams
  • Good Skills in Microsoft Office applications
  • Fluent in English

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 2021

Your application