JOB FUNCTION: Quality and Risk Management
GRADE/TITLE: Director – Senior Director
EMPLOYER: Brii Biosciences (腾盛博药)
DEPARTMENT: China Clinical Development
JOB LOCATION: Beijing, China
REPORTS TO: CMO
EFFECTIVE DATE: 3/29/2019 or earlier
SUMMARY: Responsible for quality assurance, quality control, and compliance operations
DUTIES AND RESPONSIBILITIES:
Establishes quality plans, internal risk & quality management and policies.
Designs, implements and maintains QA and compliance programs and infrastructure including a SOP system, training program, and perform internal and external audits.
Establishes, maintains, and ensures effectiveness of quality programs and documentation to assure compliance according to GxP regulation & environment.
Serves as an in-house advisor on GxP compliance.
Provides GxP Quality Assurance oversight of vendors and maintain quality agreements.
Writes, reviews, approves and maintains Standard Operating Procedures.
Ensures training programs to meet GxP and ICH requirements.
Directs development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GxP regulations and applicable country specific standards.
Oversees compliance auditing program to fulfill regulatory requirements.
Provides expertise and guidance in interpreting and implementing governmental and agency guidelines to assure compliance.
Follows applicable regulations, including NMPA, FDA, ICH, GxP, and company policies and procedures.
Ensures that company employees and consultants have completed the training necessary for their assigned responsibilities.
Provides Quality Assurance input to company strategic goals in form of schedules, quality plans, and budgets.
Develops and implements a comprehensive, global quality risk management system and reports to senior management on a regular basis on compliance activities and findings.
Minimum BS, Master’s degree or PhD with focus in Life sciences, Engineering, or other similar technical fields.
15+ years of relevant and current work experience in pharmaceutical industry Quality Assurance required.
Solid and demonstrable knowledge of international GxP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment.
Working knowledge of GxP international regulations.
Strong organization and time management skills.
Attention to detail with an ability to perform critical review of various types of documents.
Ability to independently solve problems and work cross-culturally.
Demonstrated ability to work as a team player with multi-disciplinary project teams.
Excellent oral and written communication skills in Chinese and English.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.