• This individual needs to be strong both on the Quality side AND analytical space. • • • HEAVIER IN DATA ANALYTICS THEN QUALITY • • Key Responsibilities: • Responsible for supporting Quality system oversight at CDMOs, metrics, and improvement including change control, events, CAPA, escalation, and risk management. • Generates Metrics / KPIs, Dashboards and Reports. • Leads and/or supports the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans. • Provides hands-on expertise in the day-to-day management of data collection systems and control within the GxP Quality Management System using digital solutions. • Assists Change Control, deviation, and CAPA owners with ensuring compliance to change procedure requirements. • Identifies and implements continuous improvement to improve processes and make them efficient and scalable. Key Skills: • Pulling & analyzing metrics • Understanding of Python, PowerBI, Smartsheets, Veeva, etc. • Computer science/science, pharma background • Heavier in data analytics then quality Knowledge and Skills: • Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing. • Experience with electronic document management systems (e.g., Veeva). • Understanding of Python, PowerBI, Smartsheet, automation, integration, Veeva, Amazon Web Services (AWS), etc. Education and Experience: • Bachelor's degree in a scientific or allied health field (or equivalent degree). • Typically requires 4 years of experience, or the equivalent combination of education and experience.