Job Details

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