Director/Senior Director, Clinical Quality Assurance
HUYA Bioscience International is a development-stage biopharmaceutical company bringing innovations from China to global markets in multiple therapeutic areas. HUYABIO’s lead compound in oncology, HBI-8000, is in late stage clinical development in Japan and Korea as monotherapy for the treatment of hematological malignancies. In the United States, HBI-8000 is being developed in combination with immune checkpoint inhibitors in solid tumors. The Company’s lead cardiovascular program, HBI-3000, is in Phase 1 in Europe. Two additional compounds are in early evaluation for oncology and cardiovascular diseases. More information can be found at www.huyabio.com
Reporting to the Vice President of Quality Assurance, this newly created management position will be responsible for the management of all Clinical Quality activities across HUYABIO GCP and GLP activities.
This role will support all Quality oversight aspects of HUYABIO global research and development, clinical development leading up to approval of CTD sections for all regulatory submissions and approvals with adherence to global guidelines, resulting in minimal audit findings for our outsourced contract partners and Regulatory Agencies.
Primary Duties and Responsibilities These may include but are not limited to:
- Attend project meetings, representing Quality Assurance and provide GCP/GPVP/GLP insight and oversight
- Perform review and gap analysis of existing quality systems and lead development and implementation of additional or alternative solutions
- Design and implement a risk- based audit program
- Plan, manage, and perform GCP/PVP/GLP audits: Investigational sites, various vendors supporting conduct of clinical studies, GCP/GVP/GLP system audits, clinical studies report, etc.
- Evaluate audit observations and trends and develop periodic compliance reports for management
- Monitor and drive quality issues to resolution. (e.g., Closure of Audit Reports, develop and track post auditing corrective actions plans, as applicable)
- Responsible for managing GCP/GPVP/GLP compliance activities / non-conformances associated with drug development programs
- Understand and interpret current pharmaceutical regulations and ICH guideline requirements pertaining to GCP/GPVP/GLP and advise the Clinical development teams on all relevant issues
- Review Clinical Development / Operations SOPs to ensure compliance with all applicable regulatory authorities
- Work in conjunction with other functions to ensure proper representation throughout the organization, as needed
- Conduct internal system audits to ensure compliance with applicable regulations, SOPs and policies and advice on process improvements in the functional areas
- Ensure annual GCP/GPVP/GLP audit plans are developed and audit activities are completed according to plan
- Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes
- Lead management of GCP/GPVP/GLP regulatory agency inspections and coordination of responses to any regulatory agency finding
- May lead change projects which have strategic impact on the organization
- Analyze trends in industry/regulatory environment that would necessitate future changes
- Facilitate and support GCP/GPVP/GLP inspection readiness activities
- Develop and provide independent periodic reports to management on overall compliance status
- Ensure that the company, its contractors, and vendors are prepared for FDA and other Health Authority GCP/GPVP/GLP inspections
- Support all Quality and compliance relations with PMDA, MHLW, and other related health authority agencies
- Support the rollout and implementation of the HUYA global training programs
- Identify gaps and improvement opportunities within the quality system and communicate changing quality and clinical compliance requirements with senior management throughout the company
- Expert knowledge of FDA and ICH GxP regulations and guidelines with focus on GCP, GLP, and GPVP
- Experience in hosting and managing GCP FDA and Health Authority inspections
- Experience identifying and evaluating risks and executing efficient and effective mitigations
- Practical knowledge and experience identifying key performance metrics for quality indicators, setting targets to maintain a state of control while identifying areas for improvement.
- Track record of strong personal performance combined with demonstrated ability to build processes and structure and constructive relationships cross-functionally in a fast growth environment
- Demonstrated problem-solving and critical thinking skills
- Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment
- Travel may be required up to 20% of the time
- Minimum of bachelor’s degree in a scientific discipline with at least 15 years of work experience in the Pharmaceutical/Biotechnology industry with at least 5 years in Quality (an equivalent combination of education and experience may be considered)
- Working knowledge of GXP guidance (ICH E6r2)
- Minimum 10-15 years’ experience gained in a pharma manufacturing environment role, minimum of 5-10 yrs at Senior Manager /Director level.
- Experience with regulatory interactions preferably with FDA, PMDA and EMA
- Preferably prior experience with both small molecule and biologics drug development
- Experience with all phases of clinical development and hands-on experience in monitoring or providing oversight for clinical trial sites
The position is full-time and the candidate must be able to be in-person in HUYABIOs San Diego Office at least 2 days per week or as needed for business activities (or as agreed with immediate Supervisor or SVP Quality).