The Quality Management System (QMS) Specialist role involves overseeing the Quality Assurance (QA) program and quality systems at the site level. This includes maintaining oversight of the QA program from a QMS perspective, running weekly CAPA Review Board (CRB) and Quality Review Board (QRB) meetings, developing high-level dashboards, preparing periodic reviews of the quality system, collaborating with cross-functional teams, writing, reviewing, and approving Deviations, CAPAs, Complaints, and Change Controls, leading cross-functional teams, developing, and executing remediation plans, and maintaining quality system KPIs. This role requires a strong background in quality assurance and compliance, with a focus on sterile manufacturing environments and a proven ability to lead compliance remediation projects, manage timelines, and communicate complex compliance concepts effectively. Minimum 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 industry ORBachelor'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 industryPreferred Qualifications: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 skillsExcellent communication skillsExperience collaborating with regulatory agencies and conducting audits or inspections