NJ Employer Quality Event Assessment and Investigation Lead (Sr. Manager) in Madison, New Jersey

PfizerJobsTitle:Quality Event Assessment and Investigation Lead (Sr. Manager)Job ID:1054082Location:Virtual Job; United Kingdom-Sandwich; United States-Connecticut-Groton; United States-Massachusetts-Cambridge; United States-New Jersey-Peapack; United States-New York-New York; United States-Pennsylvania-Collegeville; United States-New Jersey-Madison; UFull-TimeRegularAbout PfizerA career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.Role DescriptionQuality Event Assessment and Investigation Lead will be responsible for* Triage submitted cases to ascertain if the Significant Quality Event (SQE) threshold has been met and assess cases to determine if they need expedited reporting to senior management and/or regulatory authorities.* Drive SQE case management for assigned cases, including the investigation/root cause analysis, corrective/preventive action (CAPA) plan development, implementation of assigned plan components and tracking of actions to completionResponsibilitiesQuality Event Review and Serious Quality Event IdentificationAs the Quality Event Assessment and Investigation Lead, this individual will be accountable for the review and classification of submitted quality issues to ascertain if the SQE threshold has been met. He or she will ensure that each submitted issue is reviewed based on the established criteria, is categorized appropriately and completed within the required time frame to ensure that events are appropriately qualified enabling expedited investigation where necessary. This individual will be responsible for completing the necessary documentation in the quality event assessment system (QUEST) regarding the assessment of the submitted events.Quality Event InvestigationOnce assigned a qualified event (SQE), the individual will initiate the investigation of the event to confirm the chronology and details of the issue. Investigation will include reviewing relevant SOPs and supporting documents to understand what should have happened per our documented process and identifying what did not happen per the process. In addition, the investigation will include review of relevant documentation re: the event and assembling the SQE team with appropriate stakeholders (SME's, study team members, etc) to review and confirm the details of the event.Root Cause Analysis/Due DiligenceThis individual will also be required to apply a root cause methodology and/or due diligence approach to the case. The individual will be trained in the application of an appropriate methodology and will apply it as part of the management of the case. CAPA Plan DevelopmentBased on identified root causes, the individual will guide the SQE team in identifying appropriate corrective and preventive actions and conducting effectiveness checks on implemented actions to ensure they are working as expected.QualificationsQualifications:* BS-10 years or equivalent* MS/MBS - 5 years or equivalentPrevious Experience:* Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory.* Regulatory inspection experience* Process and system management experience* Detailed knowledge of clinical trial processes and relationships required* Knowledge of GCP requirements and applicable SOPs and re