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Senior Quality Assurance Director

vor 2 Monaten


Munich, Bayern, Deutschland BioTalent Vollzeit

Senior Quality Assurance Director Opportunity

BioTalent is seeking an experienced Senior Quality Assurance Director to join their team in Munich, Germany. As a key member of the quality assurance team, you will be responsible for overseeing QA activities for clinical service providers, trial sites, and internal GCP systems.

Key Responsibilities:

  • Develop and implement strategic plans for clinical quality management systems.
  • Conduct audits of external CROs, labs, and trial sites to ensure compliance with GCP regulations.
  • Manage contract auditors and internal quality assurance processes.
  • Represent QA-GCP in cross-functional teams and contribute to the development of SOPs.
  • Collaborate with the VP of Quality to further improve the GCP-related quality management system.

Requirements:

  • Bachelor's or master's degree in life sciences or a medical-related field.
  • Extensive QA GCP experience in biotech or pharma, with expertise in auditing GCP vendors and clinical trial sites.
  • Fluent in English and familiar with GCP regulations (US FDA, EMA, ICH).

This is an excellent opportunity to work with a growing company at the forefront of science and contribute to the development of life-saving products.