Senior Quality Specialist

Job Summary

To support clinical trial operational activities, the full-time Senior Quality Specialist will manage quality management software (QMS) processes, oversee compliance and quality assurance, and lead QMS activities, all while working remotely.

Key responsibilities

• Lead and project manage QMS activities including document control and non-conformance reporting
• Supervise QMS Non-Conformance reporting and investigations, ensuring root cause analysis and corrective measures are implemented
• Train QMS users and assess opportunities for QMS Lean and Process Efficiency projects

Required qualifications

• 4-year degree preferred with 5-7 years of Quality Assurance experience, or a 2-year degree with 8-10 years of related experience
• Veeva Belt certification preferred
• Experience with QMS platforms such as Veeva is highly preferred
• Proven track record of leading QMS implementations or enhancements