Clinical Quality Oversight Lead
ProClinical is advertising a vacancy for a Clinical Quality Oversight Lead vacancy with an outstanding biotechnology company that specialises in delivering innovative therapies for solid tumour treatments. This exciting company is seeking an experienced and dedicated incumbent to join their team in Shanghai.
The Clinical Quality Oversight Lead will help develop company Clinical Quality Management Strategy, along with supporting the planning and coordination of risk management activities. Furthermore, they will develop and implement clinical quality oversight plans via conduct quality control activities to ensure clinical trials are conducted according to GCP, local regulations, and SOP requirements. Finally, the Quality Oversight Lead will be expect to identify clinical operation training needs, coordinate training programs, and deliver training.
- Developing, maintaining, and overseeing GCP quality management process, including internal SOPs for clinical development activities.
- Developing Study Quality Oversight Plan for clinical trials and conducting quality oversight visits of clinical trial sites, contract research organisations (CROs), and suppliers.
- Developing, or working with QA vendor, on QA plan and conducting audits of clinical trial sites, suppliers, protocols, and study reports; reporting all audit observations to clinical sites and company management.
- Conducting system and process audits as required, such as pharmacovigilance, data management, safety, and clinical operations.
- Maintaining GCP regulatory compliance and quality performance within the company.
- Communicating quality issues to internal stakeholders, including resource requirements to maintain QA compliance.
- Preventing and mitigating quality risks that can jeopardise company interests, such as patient safety, supply continuity, and reputation.
- Auditing clinical trial sites, suppliers, protocols, and study reports and reporting all audit observations to clinical sites and company management.
- Managing Quality metrics and key process indicators reporting through monthly quality reporting.
- Executing quality compliance activities, such as SOP approval, deviation documentation, and CAPA.
- Establishing and executing GCP training programs.
- Establishing audit programs for company sponsored clinical trials.
- Hosting local regulatory and health authority inspections.
Skills and Requirements:
- At least a Bachelor of Science degree in Medicine, Pharmacy, Biology, or Nursing from an accredited college or university.
- At least 6-8 years of pharmaceutical company clinical development experience with at least 3 years of GCP auditing experience in clinical research.
- Demonstrable experience and active participation in health authority inspections, as well as performing clinical site and readiness inspections.
- A working knowledge of Pharmacovigilance systems and processes is highly preferred.
- An extensive knowledge of cGCP QA and compliance programs.
- An extensive knowledge of ICH E6, associated CFDA , and regulations is a must.
- Strong interpersonal skills, including communication, persuasion, and negotiation.
- A strong team-focused ethos, with a drive for continuous improvement and development.
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 call Stephen Qin on +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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