||Associate Director/Director, Clinical QC head
||Clinical and Regulatory Affairs
||Beijing / Shanghai
- Quality and Compliance Management in clinical product development.
- SOP and quality management system set up
- Lead inspection readiness for NDA studies
- Organize related training
- Hutch-med related SOP set up and maintenance
- Implement and deliver the agreed upon Quality Control plan which includes risk management, The scope of QC should be including all C&R functions
- Assist Clinical and Regulatory department to deliver a better compliance with relevant ICH GCP, GCP, country regulations and guidelines.
- Provide advice and support to Clinical Operations, Medical Science including Project Managers and other key stakeholders with regard to quality control, risk assessment and management, and corrective actions.
- QC activities including selected system checking, TMF review and co-monitoring activities.
- Lead the site inspection preparation and deal with the inspection with other functions
- Support QA activities.
- Coordinate internal and external resource to provide related training for C&R staffs
- At least bachelor degree in a health care or other scientific discipline. Clinical Medicine or pharmacy is preferred.
- At least 10 years’ industry experience with proven proficiency in clinical research management for drug development.
- Monitoring experience or equivalent combination of education, training and experience.
- Sound knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, CFDA/FDA/EMEA/PMDA regulation and quality.
- Knowledge of CRO or Pharmaceutical industry operations.
- Good organizational, interpersonal and communication skills.
- Good judgement and decision-making skills.
- Strong influencing and negotiation skills and excellent problem solving skills.
- Demonstrated ability to work in a matrix environment.
- Proficiency in English (written and oral) and familiarity with standard IT office tools.
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