HUYABIO™ is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective, and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. Hiyasta® the company’s first commercial product is marketed in Japan. With offices in the US, Japan, South Korea, Canada, Ireland, and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.
Reporting to HUYABIO’s Chief Operating Officer, the Senior Vice President of Quality Assurance will lead the Quality function, direct the company's training activities and initiatives, assure the quality of products and processes, and ensure the highest integrity in quality compliance. The SVP, QA will support HUYABIO’s global research and development leading up to the approval of CTD sections for all FDA submissions and approvals, with adherence to global guidelines. In addition, the incumbent will build a global Quality organization to meet HUYABIO’s corporate and drug development objectives and continue to build a team to effectively support multiple programs.
Primary Duties and Responsibilities
- Serve as the primary corporate interface for all compliance relations with FDA and other related health authority agencies.
- Responsible for overseeing the company's global quality strategies and directing the functional resources related to those areas.
- Direct the company's global training programs.
- Formulates and recommends Quality Assurance policies and programs.
- Contributes to material and finished product stability programs, transfer of validated methods to routine use, and participation of Quality Assurance staff in support of validation of methods.
- Responsible for organizational policies and standards to maintain corporate regulatory compliance while maintaining responsibility for the implementation of such policies and procedures.
- Review Final Study Reports, Manufacturing Process Documentation, Investigator Brochures, Clinical Study Protocols, and clinical trial documentation for compliance with cGCPs, cGMPs, cGLPs and other regulations and guidelines.
- Ensure the compliance of HUYABIO’s outsourced activities with respect to HUYABIO procedures as well as FDA, EU, ICH, PMDA, and other regulatory expectations and requirements.
- Identify gaps and improvement opportunities within the quality system and communicate changing compliance requirements with senior management throughout the company.
Job Qualifications and Requirements
- Advanced degree in Life Sciences required.
- Minimum of 20 years of experience in pharmaceutical development.
- Minimum 15 years in a management role within Quality Assurance.
- Experience with regulatory interactions, preferably with FDA, EMA, and PMDA.
- Preferred experience with oncology and/or cardiovascular drug development.
- Experience with both small molecule and biologics drug development.
- Experience in leading the Quality function for a biopharmaceutical company and familiarity with GxPs.
- Experience with electronic filing and database management abilities
- Experience with documentation systems and with document review and auditing. Master Control experience is highly preferred.
- Comprehensive knowledge of current US and ex-US regulatory guidelines.