Director/Senior Director, Quality Assurance

Primary Job Responsibilities:

Build and improve the quality system and to assist technical departments to attain high quality standards of company’s R&D operations.
Establish Quality Assurance function for related drug development activities.
Lead the Quality Committee to maintain and update SOPs and provide QA trainings to the research staff.
Organize internal and external QA compliance audits and provide improvement recommendations.
Serve as QA liaison for partners and regulatory agencies including hosting due diligence visits, addressing quality related questions, approving study reports and other regulatory documents.
Basic Qualifications:
 
PhD or MS Degree in life science or a related field (or equivalent).
Minimum of five (5) years of QA experience in pharmaceutical or biotech industries, including management responsibilities.
Some oversea working/training experience, preferably in a US pharma/biotech firm.
Deep knowledge and comprehension of GMP, GLP, GCP and other relevant regulations/guidelines.  
Fluent in English and Chinese, in both verbal and written forms.
Excellent organizational, communication, and interpersonal skills.