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 Manager Quality Systems & CSV (f/m/d)

(Reference No. OP2208)

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Key Responsibilities

  • Professional management of the entire Affimed quality system landscape, leading and advocating for its continuous improvement
  • Assist to ensure Affimed is in full compliance with Affimed requirements, national/international regulatory and industry requirements, and standards
  • Develop and compile pertinent quality metrics to provide oversight on quality system performance and on vendor quality performance to support quality review and guidance for senior management
  • Support implementation of electronic systems/digital solutions and quality dashboards supporting quality systems (e.g., document management systems, electronic QMS)
  • Support GxP-related computerized system validation (CSV) and provide QA oversight thereof
  • Provide support to the self-inspection program and participate in audits as required
  • Manage/conduct trainings of employees on Affimed quality system landscape
  • Provide oversight of SOP system
  • Partner with and supports Research & Development functions to ensure execution of the quality strategy/deliverables

Required Qualifications:

  • Bachelor/Master Degree in scientific or technical field, e.g. Pharmacist, Chemist, Biologist or similar
  • 10+ years in Quality Affairs and/or GxP regulated environment
  • Excellent knowledge of national and international regulations and guidelines applicable for the pharmaceutical industry especially with regard to GDP
  • Experience working in cross-functional teams and in a matrix organization
  • Strong team player supporting and guiding teams to ensure high quality standard
  • Strong communication skills
  • IT and CSV knowledge
  • Good Skills in Microsoft Office applications
  • Fluent in English
  • Willingness to travel

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).

June 2022

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