Sr. Manager / Associate Director, Clinical Quality Assurance
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. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. 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 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 of clinical documents (e.g., protocols, protocol amendments, Investigator brochures, Informed Consent, etc) to ensure compliance with ICH E6 r2 and all applicable requirements
- Support the release of Investigational Medicinal product in support of clinical trials, approve the release of product to clinical sites
- Review and approve clinical sites for receipt of Investigational Product
- Provide support to Clinical Operations for clinical planning, start-up, execution and close-out
- Perform review of Clinical Study Reports (CSRs)
- Monitor and drive quality issues to resolution. (e.g., Closure of Audit Reports, develop and track post auditing corrective actions plans, as applicable)
- 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
- Communicating Quality or compliance issues to Quality and Clinical Operations management and other stakeholders ensuring understanding as well as collaborating with impacted stakeholders to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes
- Support management of GCP/GPVP/GLP regulatory agency inspections and coordination of responses to any regulatory agency finding
- May lead change projects which have tactical and strategic impact on the organization
- Maintain awareness of trends in industry/regulatory environment that would necessitate future changes
- Support GCP/GPVP/GLP inspection readiness activities
- Provide independent periodic reports to management on overall compliance status
- Support readiness for 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 related to GCP, GLP and other applicable regulations and guidance
- Identify gaps and improvement opportunities within the quality system and communicate changing quality and clinical compliance requirements with Quality management
Job Qualifications and Requirements
- Strong knowledge of FDA and ICH GxP regulations and guidelines with focus on GCP, GLP, and GPVP
- Experience in supporting 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
Education and Experience
- Minimum of bachelor’s degree in a scientific discipline with at least 5-10 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 5-10 years’ experience gained in a pharma manufacturing environment role, minimum of 5 yrs at Senior Manager /Associate 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
This position is full‐time, and the incumbent must be available to attend company meetings and conduct business in person at HUYABIO’s Del Mar, CA office at least 2 days per week, or as agreed upon with immediate supervisor or SVP Quality.