职位描述

Primary Duties:Conducts wide range and GxP (Good Practices Quality Guidelines and Regulations) complex audits,(i.e directed, for-cause, pre-clinical, toxicology sites, etc) in accordance with QA (Quality Assurance)risk-based processes.Assesses compliance of clinical investigator sites, vendors, study activities, pre-clinical research activities, data, and reports, submissions, and PCO (Pfizer Country Organization) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as Pfizer policies, procedures and industry standards. Comprehensive working knowledge of Quality Assurance, regulations and auditing.Conducts QA (Quality Assurance) audits reports, results to project team personnel and management ,and interacts with various teams to ensure corrective actions are taken to bring QA observations to closure as applicable.o Audit preparation and notification to key stakeholders (e.g. review of audit and inspectionhistory and SOPs)o Conducts audits of clinical investigator sites, nonclinical laboratory studies and vendors ofsame.o Conducts audits of regulatory documents and marketing applications.o Conducts PV (PharmacoVigilance) related audits at Pfizer sites/country organizations,and vendors.o Conducts risk assessments of licensing and/or acquisition products/compounds.o Conducts audits of vendors (e.g. CROs (Contract Research Organizations), Phase 1facilities, etc.)o Conducts for-cause, directed audits and complex audits?？Serves as member of project team with participation in the applicable forums, providing compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls.?？Develops constructive customer relationship across stakeholders; may lead teams across functional lines and consistently demonstrates effective straight talk.?？Develops and delivers awareness sessions with minimal supervision on various GCP (Good Clinical Practice), GLP (Good Laboratory Practices), PV topics internally and externally.?？Acts as a strong technical resource and is called upon to resolve GCP/GLP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, GLP, PV regulations and guidelines as well as local regulations.?？Consistently demonstrated experitise in the use of different Pfizer systems.?？Strongly interacts with QA colleagues at other Pfizer locations to ensure consistency in application of the QA strategy and to promote standardization of auditing approach within QA.?？Contributes to QA by undertaking a variety of roles or assignments to further develop internalprocesses and people.?？Routinely suggests new audit techniques/aids in areas of technical expertise; strong ability tooperationalize create ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking.?？Design and actively participate in special assignments on various project teams and work streams as determined by QA management.?？Drives customer relationships and delivery of quality improvement recommendations forstakeholders; often influences outcomes of team decisions.?？Actively support regulatory inspections or corporate audit activities.?？Ensures rapid communication of QA issues, including potential misconduct or issues of significant deviation with projects/products, to appropriate leaders and colleagues.?？Provides training and mentorship to less experience members of MQA (Medical Quality Assurance) staff.?？Actively engage in appropriate activities to influence and meet the changing needs of the regulatory environment through QA and other appropriate venues.?？Exemplify ability to work in a culturally diverse environment.?？Exemplify OWN-IT behavior and promote an OWN-IT culture.?？Effective participation in endorsed, non-project initiatives external to MQA that have significant, measurable deliverables.?？Oversight of key, management-endorsed, internal MQA work streams or projects.?？Subject matter expertise representing MQA at cross-functional forums and/or projects as endorsed by MQA management.?？Requires approximately 30-50% time for conducting audits (including travel) and attending QA meetings. For site based auditors (i.e. GLP), the travel requirement is up to approximately 25%.Prior Experience Preferred?？8 or more years of relevant pharmaceutical experience (i.e., drug development, clinical and/or nonclinical research, regulatory compliance, clinical study monitoring or Pharmacovigilance) including at least 2 years previous clinical/nonclinical Quality Assurance experience conducting a broad range of audits.Technical Competencies:?？Clinical/Regulatory, Nonclincal Expertise (Essential): Broad knowledge of the drug development process, GCP/GLP/PV guidelines, and applicable regulations is essential.?？Business Acumen/Attention to Detail (Essential): Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.?？Technical Expertise/Depth and Breadth of Knowledge (Essential):？Familiarity with existing company systems,policies and procedures and knowledge of multiple therapeutic areas and nonclinical study conduct, including all Pfizer projects/premier products is desirable.?？Autonomy (Essential) ？Demonstrated ability to work independently.?？Communications：？Able to communicate complex information andanalyses to a variety of scientific and nonscientificaudiences in both verbal and writtenformats.Behavioral Competencies:Competency Detail / Comments (specific skills, etc.)?？Teamwork (Essential) ？Strong interpersonal skills with the ability to work effectively in teams.?？Influencing (Essential) ？？Ability to influence and negotiate.?？Decision Making (Essential) ？？Demonstrates good judgment and decision making.?？Time Management (Essential):？Ability to multi-task and manage time efficientlyand effectively.?？Cultural Agility (Essential) 职能类别： 药品生产/质量管理

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