Senior Quality Manager GMP (f/m/d)

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