• 招聘类型：社招
• 工作性质：全职

职位描述

General Description:

The Director, Medical & Clinical Quality Assurance, China APAC is responsible for implementing and maintaining a risk based, proactive, and phase appropriate approach to Quality Assurance. This position will be responsible for ensuring research &development, medical affairs activities in China and APAC regions are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established global quality standards and practice.

Essential Functions of the job:

Manage and oversee the Medical & Clinical QA activities in the China, APAC region:

• Overall responsible for quality oversight of clinical development activities throughout the product lifecycle
• Responsible for creating and managing annual CQA and audit plan
• Manage QA Audit program for clinical vendor qualification & routine assessment, clinical site audits, internal audit of key development processes, affiliates as appropriate
• Conduct quality review of essential clinical documents, regulatory dossiers/submissions
• Lead inspection readiness activities of BeiGene, critical clinical vendors and clinical investigator sites
• Host Health authority inspections of BeiGene, clinical investigator sites and vendors (as appropriate)
• Provide GCP & quality guidance to clinical & medical study teams
• Harmonize & align local QA procedures to global quality standards, such as; Investigations, Deviations, CAPAs, Audits, Vendor Management Systems, training, SOPs, etc.
• Manage & report significant quality events (SQE) and QS deficiencies to senior management
• Provide GCP training to medical & clinical teams as needed
• Define, collect metrics on quality KPIs to drive continuous improvement
• Coordinate with Global QMS team on analysis of quality KPIs
• Participate in budget forecasting, planning and tracking; monitor activities to stay within budget
• Provide coaching and mentoring of junior staff with training/orientation/qualification of new Quality staff
• Promote quality culture and continuous improvement
• Other duties as assigned

Supervisory Responsibilities:

• Lead a team of Quality professionals and or consultants to enhance performance and maintain accountability for the implementation of QA systems
• Expert knowledge of GCPs and GLPs, particularly FDA and ICH requirements
• Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
• Promote continuous improvements in quality systems and department infrastructure; assist with creation/revision of appropriate SOPs
• Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
• Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
• Proven ability in setting strategy for and driving quality process improvement initiatives
• Strong leadership experience and mentoring skills
• Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations
• Effective and balanced management skills in building and supporting highly effective teams

任职条件

Qualifications:

• Bachelor degree and above
• Excellent verbal and written communication skills
• Ability to effectively collaborate in a dynamic environment
• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint

职位要求

• 学历要求：本科
• 工作经验：无
• 外语要求：不需要
• 管理经验：需要

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日