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Position Description:
1. Establish and improve the whole chain quality assurance system of clinical trials to ensure compliance with international (FDA, EMA,TGA,ICH, etc.) and domestic (NMPA) regulations.
2. Organize and manage the whole chain inspection, supervision, quality control and CAPA of clinical trials.
3. Guide, review and approve standard operating procedures, rules and regulations.
4. Be responsible for the establishment and improvement of training system and professional assessment of clinical trial related posts.
5. Be responsible for the daily management, performance appraisal, technical guidance and training of the quality assurance and training department.
6. To ensure the implementation of the quality control plan of the clinical project and the on-site verification by the regulatory authorities of various countries.
7.To implement other tasks assigned by line manager timely.
Qualifications:
1.Master degree, major in Medical, Pharmacy or Pharmacology.
2.At least 15 years working experience in similar positions in large international or domestic pharmaceutical enterprises and CRO companies, and similar position experience in a third-party inspection company is preferred.
3.Rich experience in international reporting quality system construction, training, inspection and certification, and familiar with various regulations and guiding principles related to ICH / GCP and FDA / NMPA/EMA/TGA clinical trials.
4.Strong leadership, judgment, communication and innovation skills.Good English listening, speaking and writing skills.