长沙招聘

工作职责:

Contributes to maintain and oversee the implementation of GCP quality management system (QMS) and associated strategy, processes, tools, and technologies for clinical development activities in China, consistent with the enterprise-wide GCP QMS strategy developed by Clinical Development Quality (CDQ) in Clinical Sciences and OperationsContributes to the implementation of QMS strategy in China.

Maintains the Level 1 GCP Quality documents.

Promotes the consistency and compliance with regulatory expectations and company standards through quality planning, monitoring, control, and improvement activities.

Acts as a point-of-contact (POC) and subject matter expert (SME) for clinical quality requirements and activities in China for assigned portfolios, studies or vendors, emphasizing Quality-by-Design (QbD) principles.

Implements the strategy and activities related to inspection readiness for clinical development conducted in China, partnering with local Medical Quality Assurance to prepare for and manage regulatory inspections of the GCP quality system.

Implements the strategy and activities related to audit response management, serving as the primary point of contact for Corporate Audit, Clinical, and vendors for GCP-related process and vendor audits.

Assesses and ensures, in partnership with the global CDQ Vendor Quality Management Lead, that clinical trial vendors used locally have the appropriate GCP quality system components and capabilities in place to meet internal and external/Regulatory quality standards.

Leads the development of annual Quality Plans for Development China functions and the China clinical trial portfolio and associated key vendors.  Leads systematic quality oversight, control, and improvement efforts to achieve and maintain quality standards

Supports GCP quality event reporting, assessment, investigation, and remediation activities for GCP quality issues related to China clinical development activities. 

Plans, prepares, conducts, and reports on Quality and Compliance Assessments to identify areas for further analysis and remediation for the assigned portfolio or studies.

Acts as an SME in driving adherence to GCP and Pfizer’s CMCD environment.

Contributes to develop and implement appropriate GCP quality-focused programs for China

Audit and Inspection Readiness:

Leads inspection readiness and self-assessment activities for clinical development programs conducted in China for the assigned portfolio or studies.

Partners with local Medical Quality Assurance to prepare for and support regulatory inspections of the GCP quality system.

Leads audit response management, serving as the primary point of contact for Corporate Audit, Clinical, and vendors for GCP-related process and vendor audits.

Leads local GCP vendor quality assessment to ensure that selected vendors have the capabilities to meet internal and external quality standards.

Leads the development of annual Quality Plans for Development China, CS&O functions and key vendors.  Leads systematic quality oversight, control, and improvement efforts to achieve and maintain quality standards.

Quality Event Management:

Supports GCP quality event reporting, assessment, investigation, and remediation activities for GCP quality issues related to China clinical development activities.

Act as local SME in facilitating RCA for SQEs related to China and follow through the implementation of correspondent CAPAs

Portfolio Quality Management:

Leads the development of China Portfolio Quality Plans (if applicable) and associated regular quality reviews with appropriate leadership;

Holds portfolio leadership accountable for GCP quality across all studies in the assigned portfolio;

Communicates key quality information (e.g. inspection/audit learnings) across study teams, serving as a quality expert and liaison to relevant governance meetings;

Continuously reviews quality data for the portfolio, partnering with the analytics organization to identify trends, escalate issues, and support defining remediation activities, where necessary;

Ensures that China portfolio quality metrics are monitored and communicated to governance and that quality deviations are identified and addressed in a timely and appropriate manner;

Partners with key stakeholders to properly escalate and mitigate portfolio quality issues;

Advises DC and CRDC leadership to drive development and execution of remediation strategies for identified portfolio quality issues in China;

Facilitates remediation actions and track/ensure timely completion;

Supports GCP inspections as needed.

Vendor Quality Management:

Establishes and leads the development of Vendor Quality Plans and associated regular quality reviews with appropriate leadership;

Holds vendors accountable for GCP quality across all studies they support in China;

Maintains line-of-sight into vendor quality issues across various study types;

Communicates key quality information (e.g. inspection/audit learnings) across vendor points of contact, serving as a quality expert and liaison to relevant governance meetings;

Continuously reviews quality data for vendors, partnering with the analytics organization to identify trends, escalate issues, and support definition of remediation activities, where necessary;

Ensures that vendor quality metrics are monitored and communicated to governance and that quality deviations are identified and addressed in a timely and appropriate manner;

Partners with key stakeholders to properly escalate and mitigate vendor quality issues;

Advises vendor leadership to drive development and execution of remediation strategies for identified quality issues in China;

Facilitates vendor remediation actions and track/ensure timely completion.

GCP Quality Culture:

Drive cultural programs across clinical development colleagues and vendors to sustain a focus on GCP quality (e.g., quality goals, awards, change champion network)

Conduct knowledge sharing events that enhance continuous learning and the application of GCP quality knowledge (e.g., case studies, Senior Leader Forum, Learning Week)

Ensure that learning and feedback are incorporated into QMS knowledge management systems to facilitate knowledge transfer, continuous improvement and enhance Pfizer’s Quality-driven culture

Monitor the GCP Quality culture of Pfizer’s clinical development organization and vendors via regular assessments and resulting action planning efforts across clinical development

Internal and External Collaborations:

Engages with internal and external experts to monitor trends, incorporate learnings and promote the disciplines of portfolio and vendor quality management and culture in China.

任职资格:

5-10 pharmaceutical industry working experience.

With clinical operation experience.

Good verbal and written English skill.

Clinical development quality experience is preferred.

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。