Global QMS Harmonization Lead

Katalyst CRO; Jacksonville (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Staff Quality Specialist in Jacksonville, FL to harmonize and streamline QMS procedures, and to lead global standardization efforts across multiple subprocesses. The role partners with cross-functional teams to define future-state workflows, document controls, and ensure compliance with regulatory standards.

The ideal candidate will drive process simplification, maintain audit-ready documentation, and support quality system transformation initiatives across the

Qualifications

• Bachelor’s degree in a related discipline; MBA/MS preferred.
• Minimum 7+ years of experience in Quality Systems or related fields.
• Experience with QMS harmonization, remediation and standardization.
• Knowledge of ISO 13485, FDA QSR/QMSR, EU MDR and global standards.
• Experience with eQMS, PLM systems and document management tools.
• ASQ certifications (CQE, CQA, CMQ/OE) desirable.

Responsibilities

• Harmonize QMS procedures, work instructions, and forms across subprocesses.
• Identify opportunities to simplify, standardize, and globally harmonize processes.
• Collaborate with stakeholders to design future-state workflows and controls.
• Develop redlined revisions and consolidated documentation for scalable processes.
• Assess current-state processes for redundancies, gaps and improvement opportunities.
• Support governance, training materials and change-management activities.
• Ensure revisions are audit-ready and compliant with regulatory requirements.

Skills

QMS expertise

Process improvement

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in a related field

MBA/MS preferred

Tools

eQMS

PLM systems

Document management systems

Microsoft Office

Job description

Katalyst CRO is seeking a Staff Quality Specialist in Jacksonville, FL to harmonize and streamline QMS procedures, and to lead global standardization efforts across multiple subprocesses. The role partners with cross-functional teams to define future-state workflows, document controls, and ensure compliance with regulatory standards.

The ideal candidate will drive process simplification, maintain audit-ready documentation, and support quality system transformation initiatives across the