Director, Biologics QA

Kelun Pharmaceutical
Chengdu, China
Mar 27, 2018
Required Education
Bachelors Degree
Position Type
Full time

Director of Biologics QA is responsible for building and managing a biologics QA team, establishing and maintaining quality assurance systems, qualifying and auditing third parties/suppliers, ensuring new facilities and production lines in compliance with cGMP regulations, managing deviation reports and CAPAs, and providing quality annual reports.

Key responsibilities:

·         Responsible for building and managing a QA team of biologics, including therapeutic monoclonal antibodies, bispecific antibodies, ADC, and fusion proteins.

·         Responsible for establishing, maintaining and continuously improving the quality assurance system.

·         Responsible for implementing internal quality management system and obtaining various types of GMP certifications.

·         Responsible for coordinating quality audits by third-party audit departments and customers.

·         Assess and audit material suppliers, establish and maintain a list of qualified suppliers.

·         Assist in the design and construction of new facility and production lines, ensure that all facilities and equipment comply with GMP regulations.

·         Organize and coordinate validations and verifications.

·         Establish management system for quality control and ensure preparation of quality management system documents.

·         Responsible for organizing quality-related training.

·         Responsible for deviation investigations and CAPA assessments.

·         Assist in investigating and handling quality complaints.

·         Responsible for product quality review analysis and providing annual quality review analysis report.

Basic Qualifications:

·         Bachelor’s degree (master or higher preferred) in pharmacy, bioengineering, pharmaceutical engineering, biochemistry or related fields.

·         Ability to communicate in English and Mandarin.

·         A minimum of 5 years of experience in quality management of biopharmaceutical products.

·         Experience in facility construction, production site verification, and GMP certification (US or EU certification).

·         Experience in organizing a team to build a quality management or quality assurance system.

·         Experience in Quality Management in Europe and the United States is preferred.

·         Familiar with drug regulatory policies and GMP regulations.