Position Title: Clinical Quality Manager (CQM)
BU /Line: China R&D Center (CRDC), Development Operations (DevOps), Worldwide R&D (WRD)
Discipline / Job Family ： Clinical Trial Process Quality (CTPQ)
delphi免费开发工具Location: Zhangjiang Hi-Tech Park, Shanghai, China
Role Purpose: Instill concepts of Clinical Quality Management and Inspection Readiness through DevOps China to ensure that clinical trial project work is conducted to internal and external standards and can withstand Regulatory Inspection. To ensure that DevOps China organization are compliant with: ICH GCP, Declaration of Helsinki, relevant national and international regulations and standards, Pfizer SOPs and standards.
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This position will include:
ascii码表扩展>制作安卓app软件formation fee1. Interaction with a diverse range of stakeholders both internally and externally, potentially including representatives from regulatory agencies, industry contacts, leaders and representatives from across the Pfizer lines (e.g. Development Operations , BU/RU, Regula
tory Compliance, Medical QA, Corporate Audit, Legal, BU/RU, PharmSci)
2. Ability to develop excellent relationships with peers and leaders proactively identifying compliance/GCP/regulatory issues and successfully leading or participating in initiatives which result in continuous improvement and quality deliverables
3. Understanding of regulatory requirements, associated clinical trial challenges and development of ways to overcome obstacles to quality deliverables
4. Comprehensive knowledge of GCP, regulatory requirements and quality management, inspection readiness, CAPA, Quality Management Systems, audit/inspection process, clinical trial processes and systems
Organizational Relationships:· Reports to CTPQ Group Lead Shanghai· Matrix relationship to the Head of Clinical Quality Management in CTPQ Primary Duties: Quality Management and Compliance:· Lead Quality and Compliance Assessments (QCA): planning, conducting, report-out· May coordinate and manage the DevOps Compliance Pl
an (ADM02) in DevOps China; ensure DevOps China training compliance· Act as primary contact for DevOps China line Quality Roles or Business Process Owner· Proactively track and manage compliance in DevOps China to the required standards and SOP requirements to ensure successful inspection outcomes· Organize and lead a quality management and inspection readiness forum within DevOps China, which includes lead quality roles and proactively manages compliance with quality standards and inspection readiness activities. May drive/lead meetings· Act as point of contact on needed basis in DevOps China for internal audit groups related to audit planning, conduct and response support
position和location的区别· Provide service of DevOps China Audit Coordinator as necessary
· Contribute to the review of new and revised SOPs to determine impact on DevOps China business and compliance capability

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