Quality Assurance Manager (f/m/d)

Job Description Summary

MiGenTra is seeking a Quality Assurance Manager with a strong background in setting up, maintaining, and continuously improving GCP quality management systems. The Quality Assurance (QA) Manager will establish and run the QA system to provide the quality framework for regulatory compliant clinical trials in the field of biosimilar, cell and gene therapy, and vaccine development.

Key Responsibilities

  • Set-up, maintenance, and continual development of QA-system according to the requirements of pharmaceutical development
  • Identifying needs and challenges in process definitions and coordinating continuous improvement
  • Proactive support in setting-up and maintaining the SOP landscape including writing and review
  • Proactive support in project management from a quality assurance perspective including managing Quality Assurance agreements, performing quality review of GxP protocols, specifications and reports and ensuring GxP Data Integrity
  • Oversee and coordinate risk management activities
  • Coordination and performance of customer audits/ health authority inspections and their follow-up
  • Coordination and performance of supplier qualification activities
  • Preparation of regular quality planning and review
  • Coordination, conduct and documentation of trainings
  • Compliance activities tracking and review
  • Manage the implementation and validation of electronic systems for pharmaceutical development

Qualification & Experiences

  • Degree in pharmacy or life science (Master or PhD [preferred]) or comparable qualification and experience
  • At least 10 years of experience in quality management in biopharmaceutical development, thereof at least 7 years in clinical QA / GCP
  • Experience in set-up and maintenance of quality management systems
  • Experience in set-up and validation of electronic systems in the pharmaceutical environment
  • Proven ability to be flexible and adaptable within a changing dynamic environment and enjoy working in a fast-paced startup environment
  • Excellent knowledge of applicable regulatory framework and laws
  • Excellent self-organization skills and team driven spirit
  • Excellent communication skills in German and English (both written and spoken)
  • Proficiency in MS-Office applications

Applicants Contact

Beatrice Wiesner, People & Talent Manager

Beatrice Wiesner
People & Talent Manager

Phone: +49 (0) 30 3229 35 133
Email: hr@migentra.com