Senior Quality Assurance Manager

4 days ago


Ballerup, Ballerup Kommune, Denmark Symphogen Full time
About the Role

We are seeking a highly skilled Senior Quality Assurance Manager to join our team at Symphogen, a subsidiary of Servier and antibody center of excellence primarily focused on oncology and immune oncology.

Job Summary

The successful candidate will be responsible for further developing and maintaining the Quality System, including international shared CMC procedures and local Symphogen Quality Management System. This role requires a strong understanding of GMP compliance, quality management systems, and process development.

The ideal candidate will have a relevant academic degree in life science (MSc pharm or similar), at least 5-10 years of experience working with QA and development, and up-to-date GMP knowledge. Experience from the biopharmaceutical industry with IMP manufacturing for clinical trials is essential.

Key Responsibilities
  • Maintenance of the Symphogen Electronic Document Management System, Veeva Vault
  • Participate in project development work with GxP QA expertise providing GMP compliance
  • Evaluation and approval process including audits of our CDMO's (Contract Development Manufacturing Organizations)
  • Supervise GMP manufacturing of clinical trial material at our CDMO's
Requirements
  • Relevant academic degree in life science (MSc pharm or similar)
  • At least 5-10 years of experience working with QA and development
  • Up-to-date GMP knowledge, including current FDA, EMA, and ICH guidelines within the pharmaceutical area
  • Experience from the biopharmaceutical industry with IMP manufacturing for clinical trials
What We Offer
  • A competitive salary based on qualifications: estimated salary range €80,000 - €120,000 per annum
  • Flexible working hours
  • Strong cross-functional teamwork, room for individual performance and development, passionate, inspiring, and fun colleagues
Company Overview

Symphogen is a leading antibody discovery and research platform company focused on oncology and immune oncology. Our approach and capabilities are well-suited for combination therapies at the core of future cancer treatment. We are located in Ballerup in the greater Copenhagen area and currently employ approximately 150 people.



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