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 GCP (f/m/d)

(Reference No. OP2101)

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Key Responsibilities

  • Establish and maintain quality systems in a manner consistent with Affimed requirements and standards and current regulatory requirements
  • Establish and conduct internal trainings of Affimed employees, perform self-inspections and contribute to the continuous improvement of the quality management system
  • Conduct GCP Audits (System Audits, Trial Master File Audits, Site Audits, Vendor Qualification, Project Audits), including a close follow up with auditees to agree on CAPA-plans with the goal of risk mitigation
  • Coordination, preparation and follow up of regulatory inspection at Affimed
  • Provide QA support for internal and external project and team meetings
  • Partners with Regulatory, Clinical Operations/Clinical Development to ensure alignment with all clinical aspects and support functions in executing the quality strategy/deliverable
  • Interfaces with internal and external groups for resolution of quality issues
  • Review and support revision of documentation with regulatory significance (Study protocol, IMPD, IB, SOPs etc.)

Required Qualifications:

  • Bachelor/ Master degree
  • At least 3 years in Quality and/or GCP regulated environment
  • Knowledge of national and international regulations and guidelines applicable for the pharmaceutical industry especially with regard to GCP
  • Quality specific certified trainings are of advantage (e.g. Auditor Certificate)
  • Ability and experience working in cross-functional teams and in a matrix organization
  • Fast comprehension ability to oversee complex correlations and to make efficient decisions and provide solutions
  • Strong team player, supporting and guiding teams
  • Strong leadership and communication skills
  • 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).

February 2021

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