Supplier Quality Specialist

Global Product Quality Specialist12-month contract Remote EST hours, travel required for audits The Global Product Quality Specialist supports Supplier Quality and Global Quality operations through audit management, vendor oversight, compliance activities, and quality systems support within a GMP-regulated environment. This role partners cross-functionally with internal teams, suppliers, affiliates, and external auditors to ensure compliance with internal quality standards and global regulatory requirements.ResponsibilitiesSupport Global Product Quality and Supplier Quality initiatives, including inspections, audit programs, and global compliance activitiesCoordinate and maintain internal and external audit schedules to ensure timely completion of required auditsPerform and support supplier and external audits as neededTrack audit status, follow up with auditors, and ensure completion of audit-related activitiesMaintain Audit Plans, Approved Supplier Lists, and vendor data within TrackWise and related Quality Management SystemsSupport vendor management activities including risk assessments, vendor deviations, audit observations, CAPAs, and Quality AgreementsProvide updates to global quality databases related to contracts and supplier agreementsCompile and report KPIs, audit metrics, and compliance data related to outsourced GMP activitiesSupport Quality Management System (QMS) projects, regulatory compliance initiatives, process improvements, and training documentationCollaborate with global cross-functional teams to ensure compliance with GMP/GxP requirements and internal quality standardsQualificationsBachelor’s degree required4–7 years of Quality experience within a regulated industryMinimum 3 years of auditing experienceExperience in GMP/GxP environments requiredExperience with supplier/vendor quality management preferredFamiliarity with TrackWise or similar QMS platforms preferredStrong organizational, communication, and project coordination skillsPreferred BackgroundPharmaceutical, biotechnology, medical device, or regulated manufacturing industry experienceSupplier Quality, Vendor Quality, QA Compliance, or Quality Systems experienceExperience supporting internal/external audits, CAPAs, deviations, and regulatory inspections