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Quality Management Director

vor 2 Monaten


Zug, Zug, Schweiz PSI Vollzeit

About the Role:

This position oversees the quality management of PSI. The Director of Quality Management is responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards.

Key Responsibilities:

  • Develop and implement quality management systems.
  • Manage quality audits and investigations.
  • Oversee vendor qualification and computer systems validation.
  • Provide training and support to staff.
  • Act as the primary QM contact for PSI Operations divisions.

Requirements:

  • College or university degree.
  • Minimum 7 years of experience in Clinical Research.
  • Minimum 5 years industry experience in the capacity of a QA auditor or equivalent.
  • Excellent knowledge of ICH GCP guidelines, FDA/EMA regulations, and applicable local regulations.
  • Strong communication and interpersonal skills.