R&D Quality Project Lead

Job Summary

A company is looking for an R&D Quality Project Lead and Business Analyst Senior Manager.

Key Responsibilities

• Provide strategic input and project management oversight across various functions within R&D Quality
• Manage and deliver clinical quality-related projects and initiatives to enhance effectiveness and standardization
• Analyze data and processes to identify areas for improvement and support communication among project teams

Required Qualifications, Training, and Education

• B.S. in a scientific or quality-related field with 5-7 years of relevant experience, or M.S. with 3-5 years of experience
• Strong knowledge of Good Clinical Practices (GCP) and familiarity with GVP, GMP, GDP, and CMC operations
• Demonstrated proficiency in Microsoft Office applications and Smartsheet
• Experience with project lifecycle management and methodologies such as Lean Six Sigma and Agile
• Experience in the pharmaceutical, biotechnology, or device industry, with US FDA inspection experience preferred