Senior Associate, R&D Compliance

Job Summary

A company is looking for a Senior Associate, R&D Compliance.

Key Responsibilities

• Support the Research and Development Quality Manager and provide quality oversight for clinical trial activities
• Participate in Clinical Study Team meetings and review key study documents for quality input
• Assist in risk-based GCP audits and support inspection readiness and management activities

Required Qualifications

• High school/GED with 4 years, Associate's with 2 years, Bachelor's with 6 months, or Master's with relevant quality compliance experience
• Minimum of 3 years in the biopharmaceutical industry in Quality Management or Quality Assurance
• Experience with regulatory authority inspections and quality management systems
• Understanding of Clinical R&D activities and global regulations, including Good Clinical Practice
• Knowledge of regulatory submission and inspection management procedures