Senior Quality Assurance Manager

24 hours ago


Ballerup, Ballerup Kommune, Denmark Symphogen Full time

The role of a Senior Quality Assurance Manager at Symphogen presents an exceptional opportunity to contribute to international biotechnology development activities within early and late-stage projects of antibodies, including bi-specific and Antibody Drug Conjugates (ADC's).

Job Overview

You will be part of the international Servier CMC quality organization, influencing the shared quality system. Located in Ballerup, you will have close connection to the local biotech research and development environment and be responsible for local quality.

Responsibilities
  • Maintain and further develop the Quality System, encompassing international shared CMC procedures and the local Symphogen Quality Management System.
  • Manage and maintain the Symphogen Electronic Document Management System, Veeva Vault.
  • Collaborate on project development work with GxP QA expertise, ensuring GMP compliance.
  • Participate in evaluation and approval processes, including audits of our Contract Development Manufacturing Organizations (CDMOs).
  • Oversee GMP manufacturing of clinical trial material at our CDMOs.
  • Provide support for documentation management and review from suppliers and CDMOs to ensure readiness for product release.
Requirements
  • A relevant academic degree in life science (MSc pharm or similar) and at least 5-10 years of experience in QA and development.
  • Up-to-date GMP knowledge, including FDA, EMA, and ICH guidelines within the pharmaceutical area.
  • Experience in the biopharmaceutical industry with IMP manufacturing for clinical trials.
  • QA management experience in project work within a multi-cultural environment.
  • Interest in building up and streamlining processes and systems to support the quality system.
  • People management skills, as potential successor for the Symphogen QA Director.
  • Fluency in Danish and English, verbal and written (French speaking is an asset).
  • A strong communicator who can listen, be pragmatic, and flexible in approaching problems and challenges.
  • Honesty, openness, and a good sense of humor.
  • Ability to work independently and as part of a team.
Benefits
  • A challenging and versatile job in an international, innovative, flexible, focused, and committed biotech environment.
  • Competitive salary based on qualifications and flexible working hours.
  • Strong cross-functional teamwork, room for individual performance and development, passionate, inspiring, and fun colleagues.

We are seeking a highly motivated individual to join our team at Symphogen, a subsidiary of Servier. As an antibody center of excellence primarily focused on oncology and immune oncology, we strive to advance superior mAb therapeutics to improve the lives of cancer patients.



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