QMS Consultant

Senior Manager / Associate Director, Quality Management Systems (QMS) Consultant (6-Month Contract) Position Summary The QMS Consultant (Senior Manager / Associate Director level) will support the development, implementation, and maintenance of the organization's Quality Management System to ensure compliance with regulatory requirements and industry standards. This is an initial 6-month contract with potential for extension based on business needs. Key Responsibilities Execute QMS strategies aligned with business objectives Manage and optimize the eQMS, including workflow configuration, upgrades, and process improvements Lead inspection readiness and support regulatory inspections (e.g., FDA, EMA, state) Oversee GxP systems lifecycle, partnering with IT, vendors, and business stakeholders Manage Deviation, Change Control, and CAPA processes, including continuous improvement initiatives Track and support development of GxP SOPs and policies across functions Analyze quality metrics and present KPIs for Quality Management Reviews Qualifications Bachelor's degree in Life Sciences, Engineering, Quality, or related field (Master's preferred) ~5+ years of experience in quality within a regulated industry (pharma, biotech, medical device, etc.) Strong knowledge of QMS, GMP, and regulatory compliance Experience with Veeva Vault (QMS, QualityDocs, RIM) preferred Proven project management, communication, and analytical skills