Clinical QC Leader
A leading pharmaceutical company that accelerates the launch and listing of drugs across China is seeking a Clinical QC Leader to join their office in Shanghai. The organisation, which is a subsidiary of an international pharmaceutical corporation, specialises in increasing China's core competitive power in the innovation of new drugs. This is an exciting opportunity to work with a prestigious company that develops first-class drugs.
- Overseeing the development and implementation of Quality Control strategy and activities for Clinical Operation team, along with generation, review, and compliance of developed and approved procedures with company-wide quality policies and standards.
- Responsible for the development, maintenance, and communication of high-quality standards in the delivery of clinical studies.
- Securing and improving quality in Clinical Operation by providing training, implementing QC activities and driving quality initiatives.
- Providing compliance and process advice to study teams and identifying opportunities for quality and process improvements.
- Responsible for the development, implementation, and continuing review of procedural documents, and maintaining current knowledge and understanding of regulations and industry practices in relation to clinical trials.
- Supporting audits and inspections, acting as the main contact for auditors from Clinical Operation team.
- Advising and monitoring Clinical Operation team in the planning and implementation of all quality control activities and using risk management to evaluate compliance issues and develop solutions.
- Providing co-monitoring visit according to the alignment with study lead.
- Ensuring annual study and system QC plan in place, facilitating and monitoring the implementation of QC activities by Clinical Operation team.
- Analysing the quality status of the function, identifying risk/root cause and coming up with CAPA.
- Advising Clinical Operation team on CRO quality management.
- Advising/Supporting the local study team in the preparation for, conduct of, and responses to audits and regulatory inspections.
- Advising local study team in the resolution of the findings in audit and inspection reports.
- Giving regular feedback/training on audit and inspection findings to Clinical Operation team.
- Sharing learnings from audits and inspections with study team. Identifies and ensures resolution of potential risks based on previous study/systems QC results, audit and inspection results.
- Working with LMs to ensure the training compliance within function
- Identifying and organising/providing on-going and ad-hoc training to Clinical Operation staff according to training needs.
- Training new staff, including Procedural Training.
- Identifying opportunities for quality improvement and optimizing/simplifying relevant processes.
- Providing training to Investigation Site staff on GCP, ICH and local regulations, if support needed by local study team.
Skills and Requirements:
- University degree in related discipline, preferably in life science, or equivalent.
- Fluent knowledge of spoken and written English.
- At least 5 years of experience in the multinational pharmaceutical industry, preferably in Clinical Development
- Procedural Documents generating experience
- Good understanding of the drug development process and related GXP activities
- Good understanding of the skills and knowledge required for the successful delivery of a clinical study, eg. ICH-GCP, study management, site management, monitoring and local regulations
- Good knowledge of local and international regulations and guidelines
- Ability to monitor the internal and external working environment and enable changes to drive quality, implication and efficiency
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Stephen Qin at +86 21 51694107 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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