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Senior Quality Assurance Manager (m/f/x)

  • Location: Berlin
  • Salary: negotiable per year
  • Job Type:Permanent

Posted 13 days ago

  • Sector: Biotech
  • Contact: Claudia Gines Madrid
  • Contact Email: c.gines@sciproglobal.de
  • Start Date: asap
  • Expiry Date: 02 September 2022
  • Job Ref: QA_2022_15_1659540498

Senior Quality Assurance Manager (m/f/x) | Berlin | Pharma

In this position you will be responsible for setting-up, maintaining and continuously improving GCP quality management systems. As a Senior Quality Assurance Manager (m/f/x) you 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. Moreover, you will be responsible for identifying needs and challenges in process definitions and coordinating continuous improvement, as well as preparing regular quality planning and review.

What are your tasks as "Senior Quality Assurance Manager (m/f/x)"?

  • Set-up, maintenance, and continual development of QA-system according to the requirements of pharmaceutical development
  • Strong background in setting-up and maintaining the SOP landscape including writing and review
  • 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, as well as supplier qualification activities
  • Coordination, conduct and documentation of trainings
  • Compliance activities tracking and review
  • Manage the implementation and validation of electronic systems for pharmaceutical development

Your profile as a "Senior Quality Assurance Manager (m/f/x)"?

  • Academic background in life sciences or comparable qualification and experience
  • Around 10 years of experience in quality management in biopharmaceutical development, thereof around 7 years in clinical QA / GCP
  • Experience in set-up and maintenance of quality management systems, as well as in 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
  • Proficiency in English and German

About our client

Our client is a biotechnology company focused on establishing equitable access to highly qualitative biologics (biosimilars, CGT's and vaccines) in the MEA region and strengthening their local manufacturing capacities. With this aim, the company is committed to overcome healthcare inequality & is strongly positioning itself in the African market. The company has grown by 50% in the last two years and is headquartered in Berlin, with management in Berlin and Cairo.