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Quality Management Systems Specialist
4 months ago
The Quality Management System (QMS) Specialist will play a key role in the oversight of the Quality Assurance (QA) program and quality systems at the site level to support on time closures and overall QMS health.Maintain oversight of the QA program from a QMS perspective by driving on time closures and providing support for all records to ensure all systems remain compliantAssist with running weekly CAPA Review Board (CRB) to vet all CAPA proposals, communicate weekly and monthly forecasts and communicate any escalationsAssist with running weekly Quality Review Board (QRB) to cover all QMS records, holistically. With emphasis on any Deviations or Complaints that are deemed to be CriticalDevelop and maintain high level dashboards for CAPAs, Deviations, Complaints and Change Controls based off of site KPIsPrepare periodic review of the quality system for quarterly Quality Management ReviewStrong collaboration, including problem solving and continuous improvement efforts, and communication with cross functional teamsWrite, review and approve Deviations, CAPAs, Complaints and Change Controls, as requiredLead and inspire cross-functional teams, driving a culture of compliance and continuous improvementDevelopment and execution of comprehensive remediation plans to address any gaps in the quality systemWork with cross-functional teams to implement compliance improvementsMaintain quality system KPIsOther responsibilities as required Who You Are:Minimim Qualifications:Associate's Degree in Microbiology, Biology, Medical Technology, Pharmacy, Biochemistry, Engineering, or other life science discipline with 5+ years of experience in Quality Assurance and/or compliance roles within the pharmaceutical or biotechnology industryORBachelor's Degree in Microbiology, Biology, Medical Technology, Pharmacy, Biochemistry, Engineering, or other life science discipline with 3+ years of experience in Quality Assurance and/or compliance roles within the pharmaceutical or biotechnology industry Preferred Qualitfications:Strong focus on sterile manufacturing environmentsIn-depth understanding cGMP, Data Integrity and Quality SystemsProven track record of successfully leading and managing compliance remediation projects, ideally within sterile manufacturing facilitiesStrong project management skills, including the ability to prioritize tasks, manage timelines, and allocate resources effectivelyExcellent communication skills, both written and verbal, with the ability to convey complex compliance concepts to a range of audiencesExperience collaborating with regulatory agencies and conducting audits or inspections
