Clinical QA Manager/Director
This company is about to launch Pre- IPO and provide stock option to employees
a promising platform to develop career with support of a very decent team
About Our Client
Company one is a cell therapy company that is about to launch Pre- IPO abroad China with 5 first-in-class products, one of which launches the clinical trials in China/US/Canada. It will build up a manufacturing facility in North Carolina.
Company two is a oncology-immunology biopharma with 2 star products which separately got the clinical trial approval by CFDA in 2016 and is engaged in the R&D pharmacological toxicology, launching the IND in both US and China in the near future.
Develop, maintain, and oversee GCP quality management process including internal SOP for clinical development activities
Develop Study Quality Oversight Plan for sponsored clinical trials and conducts quality oversight visits of clinical trial sites, contract research organizations (CRO) and suppliers.
Develop (or work with QA vendor) on QA plan and conduct audits of clinical trial sites, suppliers, protocols, and study reports and report all audit observations to clinical sites and management.
Conducts system and process audits as required, e.g. pharmacovigilance, data management, safety and clinical operations etc.
Maintains GCP regulatory compliance and quality performance.
Responsible for communicating quality issues to internal stakeholder, including resource requirements to maintain QA compliance.
Prevent and mitigate quality risks that can jeopardize interests (patient safety, supply continuity, reputation).
Conducts audits of clinical trial sites, suppliers, protocols, and study reports and reports all audit observations to clinical sites and management
Drive a continuous improvement / on-going development mind-set together with clinical operations team and management
Manage Quality metrics and key process indicators reporting through monthly quality reporting
Execute quality compliance activities: SOP approval, deviation documentation and CAPA
Establish and execute GCP training programs
Establish audit program for sponsored clinical trials
Host local regulatory and health authority inspections
The Successful Applicant
Bachelor degree or above with 3-8 years work experience ans 1-2 years management experience.
Familiar with GCP compliance and quality Assurance.
Proven track record in multinational company or middle level biopharma.
What's on Offer
Fast promotion opportunity.
Abundant project experience.