长沙招聘

职位描述：
ROLE SUMMARY
The Quality Assurance Lead (QAL) is responsible for defining and executing the MQA China strategy and audit plan. They act as a leader in MQA and provide oversight and guidance to Quality Assurance Professionals (QAP) to allow for effective execution of the audit plan for their program. The QAL is accountable for the design and timely delivery of the audit program from start to finish. This individual identifies, mitigates and communicates Quality Assurance (QA) issues and misconduct and ensures that quality standards are consistently applied across the program in China. This individual is an expert for the China region and are up to date on current industry trends.
ROLE RESPONSIBILITIES
Leadership
? Influences leadership, and peers within MQA and peers across functional lines to develop consistent and transparent quality strategy for assigned programs. Partners with functional lines to provide expertise and guidance.
? Provides appropriate ongoing support to ensure that current talent develops the skills necessary to be a high performing MQA professional.

Audit Strategy
? Develops and represents MQA’s audit strategy for China (including vendors) and is accountable for the communication of the audit plan to the clinical/functional leads, QAPs and level 1 quality
? Responsible for development and execution of a comprehensive audit schedule for China and/or vendor entities (site audits, document audits, CRO audits, inspections)
? Supports and executes on quality programs, functional areas, vendor entities and/or assessments
? Collaborate with Project Management team at Development China (DC) to understand the status of China/Regional studies, and collaborate with MQA QALs to set up audit strategy

Risk/Quality Management
? Aware of development and regulatory strategies in a program within the China region
? Collaborates with MQA peers on program, functional area and/or vendor entity strategies to drive consistency across MQA
? Interfaces with regulatory authorities on assigned programs and represents Pfizer at industry forums
? Gathers, reviews, and analyzes quality data to support the identification of risk, and communicates findings to Area Head Asia, Direct of Clinical Site Management (DCSM) China, MQA leadership, level 1 quality and Clinical Team, and supports implementation of changes
? Collaborate with CDQ China to manage SQEs reported and provide guidance in CAPA development and effectiveness check
? Supports China Quality Oversight Committee (CQOC) for Quality Dashboard, monthly meetings and annual event.
? Provides support and serves as a back-up to Inspection Management team for pre-inspection visits and inspections.
? Reviews the self-assessment reports and provide GCP consultancy to China self-assessment activities
? Conducts pre-inspection site audits at selected sites (if time/resources allow) and provides MQA expertise and training to the site staff and the study team for inspection preparation

Operational Excellence
? Accountable for design and timely delivery of the audit program for China region from start to finish
? Ensures rapid communication of QA issues including potential misconduct or issues of significant deviation within projects, products and/or vendor entities to appropriate leaders and colleagues
? Conducts routine, for cause or directed audits
? Partners with other groups in MQA to provide oversight for local China vendor and due diligence audits (i.e. CEP vendors, central labs), inspections, investigations and other compliance related issues in China
? Works to ensure quality standards are consistently applied across the China region
? Proactively identifies opportunities for improvement within MQA
? Provides MQA expertise and GCP consultancy to the cross-function platform to ensure effective CFDA self-assessment activities
? Maintains current knowledge of industry quality trends in program
? Monitors and maintains expertise in program
? Deliver trainings to internal colleagues
QUALIFICATIONS
? Bachelor’s degree or equivalent experience is required. Advanced academic qualification/degree is preferred; equivalent relevant professional experience will be considered.
? 10+ years QA experience or relevant experience in clinical quality management, biomedical science, clinical development, or regulatory strategy preferred
? Project management experience with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities a plus
? Preferred experience in audits with a background in GCP, PV, GLP, Process or other related quality areas
? Expertise for one or more areas (Doc, PCO, Disease Area, etc.)
? (For PCO only):Expertise for one or more areas: Medical Affairs, Medical Information and Commercial
? Ability to function autonomously in a matrix model and in a team environment
? Proven ability to think innovatively and to develop and execute strategic plans pursuant to the responsibilities of the role

ORGANIZATIONAL RELATIONSHIPS
The Quality Assurance Lead will directly report into the Portfolio Team Lead. They will interact and communicate with the Clinical Team and Group Leads.
Externally, the Quality Assurance Lead will interact with regulatory bodies or vendor groups.

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。