QMS and Reporting Specialist

Primary Responsibilities

• Collaborate with GxP stakeholders to enhance deviation training programs
• Improve quality metrics
• Support QMS processes through data analysis and technology enablement

Skills & Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline
• Experience in GxP Quality Systems, QA operations, or QMS program support
• Strong understanding of GMP, GLP, GCP regulations, and ICH guidelines
• Proficiency in quality metrics, dashboards, and KPI development
• Skilled in data analysis and trending using tools like Excel or Power BI
• Familiarity with electronic quality management systems (e.g., Veeva preferred)
• Strong process thinking, analytical, and project management skills
• Excellent communication, facilitation, and technical writing abilities
• Ability to influence without direct authority and work independently
• Experience with AI-enabled tools while ensuring GxP compliance and data integrity principles is a plus