This is what you will do: As part of the Development Quality Team, you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for supporting business relationships with defined stakeholder groups in Development, Regulatory and Safety and for the delivery of risk based GCP quality management activities for these stakeholders.
You will be responsible for: Support the execution of the overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs)Support quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develops mechanisms of KQI/KRI, detection, oversight and trending with Clin development and Ops stakeholders and other stakeholders and functions such as Risk based Quality ManagementSupport global/systemic clinical quality issue investigations, which includes:In collaboration with issue owners lead Quality Event reportability assessments, investigations and Root Cause AnalysisPerform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAsActs as quality approver for Quality Issues and CAPAs as assignedSupport inspection readiness for assigned programs/portfolio including but not limited to:Provide leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical complianceProvide guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training, Mock inspection etc.)Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/Therapeutic AreaSupport continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issuesSupport in meetings driving quality and business performanceYou will need to have: Bachelor's degree in life science, or equivalent field, requiredMinimum of 6+ years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and complianceEstablished knowledge of GCP regulations and guidelines (EMA, FDA, PMDA etc.)Experience participating in regulatory inspectionsStrong collaborative, influencing and interpersonal skills – curious to understand business environmentAbility to maintain and create professional networks with stakeholdersExcellent communication skills; fluent oral and written EnglishWe would prefer for you to have: Advanced degree preferredCompetencies to be successful for this position include:Quality, process, and compliance orientedStrong interpersonal skillsCritical thinkingIntegrityCommunicationTeamworkProblem solving
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