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Director of Quality

Company: HUYA Bioscience International
Location: San Diego
Posted on: January 17, 2020

Job Description:

HUYABIO is seeking a self-motivated person to drive technical and operational Quality for all aspects of HUYABIO's global research and development efforts ("Director Quality Assurance"). 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 HUYABIO's 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 Technical review and approval of Process and Analytical Protocols/Reports, Manufacturing Process Documentation, and clinical trial documentation for compliance with GxPs and ICH guidelinesProactively monitor compliance of the companies outsourced activities with respect to company procedures as well as FDA, EU, ICH, PMDA and other regulatory expectations and requirementsSupport implementation of all strategic Quality initiatives across all HUYA cross-functional areas and global office sites and provide adept supportive leadershipEnsure 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 AgenciesOversight of diligent and timely close-out of product investigations, complaints, deviations associated with release of clinical material.Manage and oversee effective Quality oversight of the companies Vendor Management Program.Provide QA oversight and critical evaluation of all outsourced Validation / Qualification activities.Review and approve CMC sections of Regulatory filings on behalf of HUYA Quality function.Identification and resolution of quality and analytical issues associated with technology transfer.Oversight and Review of partnerships / relationships with CDMO/CTL/CRO and where appropriate, manage the relationship through Quality Technical Agreements.Support CMC/Manufacturing/Clinical and regulatory aspects of HUYABIO projects in collaboration with multidisciplinary teams according to project plans, timelines, and budgets Other: Support all Quality and compliance relations with PMDA, FDA and other related health authority agenciesSupport the rollout and implementation of the HUYA global training programsIdentify gaps and improvement opportunities within the quality system and communicate changing quality and clinical compliance requirements with senior management throughout the companyJob Qualifications and Requirements Comprehensive knowledge of current US and ex-US regulatory guidelinesExcellent 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 skillsBroad industry experience and technical background encompassing Production, Quality Assurance, Clinical Development and Quality ControlEstablished 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 sourcesAbility 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 10-15 years' experience gained in a pharma manufacturing environment role, minimum of 5-10 years at Senior Manager level.Experience with regulatory interactions preferably with FDA, EMA and PMDAPreferably prior experience with both small molecule and biologics drug development The position is full-time and the candidate must be within commuting distance to HUYABIO's Del Mar, CA headquarters. Interested candidates should submit resumes to: recruit@huyabio.com. To learn more about HUYABIO visit www.huyabio.com. HUYABIO is an equal opportunity employer. PandoLogic. Category: , Keywords: Quality Control / Quality Assurance Director

Keywords: HUYA Bioscience International, San Diego , Director of Quality, Executive , San Diego, California

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