Quality Head (VP - Chief Quality Officer)
Ethos BeathChapman
- Beijing
- Permanent
- Full-time
Industry: Pharmacy, BiotechWe are a molecular imaging contract research organization company in China. We provide outstanding contract research for new drug development using radiolabeling and molecular imaging techniques. We provide integrated solutions, including evaluating potential therapeutics, biodistribution, pharmacokinetics, and pharmacodynamics. We provide translational research using various non-clinical through Phase 0 clinical trial services. We focus on oncology, central nervous system diseases, and other chronic diseases such as coronary heart disease, diabetes, rheumatoid arthritis, etc.Job Description SummaryAs the head of the Chief Quality Officer, this individual is responsible for the overall success of the company's Quality Management System (QMS). QMS is vital to ensuring patient safety and the integrity of the data generated. We comply with all applicable laws, regulations, guidelines, and global GxP standards related to our services to deliver reliable, high-quality outcomes regardless of geography.
As a senior leadership team member, the Chief Quality Officer (CQO) leads quality assurance across the company's functions and business sectors. This individual is responsible for all organization quality, risk management, and safety assurance-related activities.MAJOR AREAS OF RESPONSIBILITY:
- Works collaboratively across the company, within China, and rest of the world to enhance and implement the Company's quality assurance through a comprehensive quality management system (QMS)
- Builds and lead a multidisciplinary quality organization that transcends business sectors and reinforces a consistent approach to meet quality standards, including strengthening and reinforcing a culture of quality excellence throughout the company and its qualified vendors
- Actively implements innovative ideas to redefine, measure, and improve quality systems
- Manages performance improvement projects, flow, and alignment to ensure milestones and key performance indicators are met within defined parameters
- Provides guidance, support, and as needed, leads regulatory inspections, suppliers, and client audits
- As part of Company leadership, promote synergies and efficiencies between the Quality Assurance team and other company departments
- Direct and contribute to quarterly quality performance meetings during which achievement status of the quality objectives and quality performance metrics are reviewed
- Advanced degree in a scientific, applied sciences, or related field
- At least 15 years of experience in quality assurance or equivalent, with a minimum of 7 years in QA leadership
- Excellent knowledge, understanding, and experience of Good Practices (GxPs) and international, national, and local regulations and laws for working in clinical and non-clinical research environments
- Demonstrated problem-solving and critical thinking skills, as well as the ability to develop processes where there is no existing roadmap
- Strong management skills with the ability to select and hire highly qualified and talented staff to meet the demands of a rapidly growing, expanding company
- Proven leadership skills as demonstrated through work history
- Excellent time management, organizational, and communication skills
- Embodies ethics and integrity in all work, respecting research codes, employees, company and broader community policies in all conduct
- Strong commitment to the team; maintains positive working relationships with diverse people, including internal team and external partners