Senior Director/Vice President, Quality Assurance
HUYA Bioscience International is a development-stage biopharmaceutical company bringing innovations from China to global markets in multiple therapeutic areas. HUYA’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 Senior Vice President of Quality, this newly created management position will be responsible for the management of all Clinical Quality and Technical Compliance activities across HUYA GxP Operations activities in US, Japan and Dublin. This role will support all technical and operational Quality aspects of HUYA 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
Identify and implement strategic Quality initiatives across all HUYA cross-functional areas and global office sites and provide adept supportive leadership.
• Ensure that the company operates in a manner which is fully compliant with applicable GxP’s and international standards resulting in minimal audit findings for outsourced contract partners and from Regulatory Agencies.
• Propose and gain leadership buy-in for key cross-functional improvements to support company efficiency or growth.
• Lead management of Global regulatory agency inspections and coordination of responses to any regulatory agency finding; Support regulatory inspections managed by other HUYABIO business entities.
• Lead and support pre-approval inspection efforts associated with regulatory filings and support regulatory inquiries associated with filings.
• Contribute to the development of regulatory strategy and provide input on pre-filing consultations, agency meeting proposals, and other regulatory correspondence.
• Serve as Compliance approver on materials distributed external to the company related to clinical products and studies.
• Proactively monitor compliance of the companies outsourced activities with respect to company procedures as well as FDA, EU, ICH, PMDA and other regulatory expectations and requirements.
• Oversight of diligent and timely close-out of product investigations, complaints, deviations associated with release of clinical material.
• Review and approve CMC sections of Regulatory filings on behalf of HUYA Quality function.
• Oversight and Review of partnerships / relationships with CDMO/CTL/CRO and where appropriate, manage the relationship through Quality Technical Agreements.
Perform review and gap analysis of existing quality systems and lead development and implementation of additional or alternative solutions.
• Support CMC/Manufacturing/Clinical and regulatory aspects of HUYA projects in collaboration with multidisciplinary teams according to project plans, timelines, and budgets.
• Technical review and approval of Process and Analytical Protocols/Reports, Manufacturing Process Documentation, and clinical trial documentation for compliance with GxPs and ICH guidelines
• Support all Quality and compliance relations with PMDA, FDA and other related health authority agencies.
• Lead and/or support the rollout and implementation of the HUYA Electronic QMS including Document Management, Training, Document Archival, Vendor Management and provide the strategy to ensure enabling processes, training and IT capability are implemented along with the electronic system.
• Identify gaps and improvement opportunities within the quality system and communicate changing quality and clinical compliance requirements with senior management throughout the company.
Job Qualifications and Requirements:
• Comprehensive knowledge of current US and ex-US regulatory guidelines.
• Excellent knowledge of Regulatory Compliance, process and analytical validation and technical transfer. Has a thorough understanding of US and international regulatory requirements as they pertain to general Quality.
• Has a thorough understanding of the regulatory process from IND through commercialization.
• Strong project management skills.
• Broad industry experience and technical background encompassing Production, Quality Assurance, Clinical Development and Quality Control.
• Established track record with evidence of excellent project management, problem solving, collaborative, leadership and communication skills.
• Strong written and oral communication skills.
• Able to grasp complex technical issues and make sound decisions based on data and information from various sources.
• Ability to foster and promote internal collaboration.
Education and Experience
• Educated to degree/masters level in relevant technical/engineering/scientific discipline, preferably multi-disciplinary with a strong technical/scientific orientation.
• An advanced degree desirable. Very good knowledge of Quality Operations (Clinical and Commercial), Quality regulations particularly in Japan, US and EU markets.
• Minimum 15-20 years’ experience gained in a pharma manufacturing environment role, minimum of 10 yrs at Senior Manager level.
• Experience with regulatory interactions preferably with FDA, EMA and PMDA • Preferably prior experience with both small molecule and biologics drug development.
The position is full‐time and the candidate must be within commuting distance to HUYA’s Del Mar, CA US headquarters.
To learn more about HUYA Bioscience, please visit www.huyabio.com. HUYA Bioscience is an equal opportunity employer.