Clinical QA Manager/Director

Shànghǎi Permanent
  • 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.

Job Description

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.

Competitive salary

Daisy Lian
Quote job ref
Phone number
+8621 6035 3432

Job summary

Job Type:
Consultant name
Daisy Lian
Consultant phone
+8621 6035 3432
Job Reference