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.