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Quality Management Director
vor 2 Monaten
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.