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  • ID
    #5486427
  • Salary
    USD TBD TBD
  • Source
    Pfizer Inc.
  • Date
    2020-11-03
  • Deadline
    2021-01-02

Reference #: 4795913ROLE SUMMARYScience is the foundation of all that we do at Pfizer. We are seeking a Senior Manager Quality Assurance Auditor who will join a diverse team of dedicated professionals driven to significantly improve the lives of patients through his/her/their work at a company whose culture is committed to developing and nurturing diverse talent so that each colleague has the opportunity to build a fulfilling career.Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non-compliance associated with Pfizer's GxP regulated operations.The Sr. Manager, PCO and Process Quality Assurance Auditor (QAA) is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP enterprise processes that span GCP, PV, Regulatory, Medical or are conducted at the Pfizer Country Offices. This role is responsible for GxP Oversight and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).ROLE RESPONSIBILITIESIndependently conduct wide range (non-routine) complex audits (minimal to no oversight - as needed)Execute audit strategy and lead process auditsAct as a reviewer of audit reports from outsourced or routine auditsAssess audit plans and quality metrics to identify potential areas of riskActively support regulatory inspections as neededIdentify and drive process improvementsDeliver awareness sessions with oversight by manager on various GxP topics internally and externallyDrive interactions with QA colleagues at other Pfizer locations to ensure consistency in application of QA strategy and to promote standardization of auditing approach within QAActively engage in discussions to determine impact of changing needs of the regulatory environmentWork with RQA colleagues on cross GxP audit plans as requiredCoach colleagues - lead training for routine and non-routine site and process auditsAdvise business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activitiesIndependently/with minimal supervision demonstrate leadership by providing clients with influence and recommendations to meet changing GxP business needsBASIC QUALIFICATIONSDemonstrates comprehensive working knowledge of business concepts and quality operationsDisplays critical thinking expertise, with ability to define and implement a strategic approach to audit based on compliance and business knowledgeStrong use of quality and auditing frameworks and applicationRoutinely suggests new audit techniques and approaches, and operationalizes to improve the audit systemAbility to identify trends within data and apply insights to make recommendations and decisionsAbility to bring recommendations to stakeholders for discussion and inputActively leads and progresses efforts to deliver operational improvementsExhibits good project management capabilitiesHas domain expertise in 2 or more technical areasAbility to work with ambiguity and adapt plan when neededExperience evaluating and understanding quality standards or their applicationUses and interprets qualitative/quantitative data to drive decision making, operationalize recommendations and understand potential impact to other areas of the businessPREFERRED QUALIFICATIONSHas 8+ years of experience (2 levels; operations and auditing required)Lead audit teams (2-6 ppl per team)Demonstrates stakeholder and conflict management (communications, relationship management)Negotiates needs and acquires feedback on audit outcomePreferred experience in audits with a background in GCP, PV, GLP, Process or other related quality areasExpertise in 1+ major areas (Doc, PCO, Disease Area, etc.); and 2+ minor specializations OR 2+ major and 1+ minorAbility to function autonom

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