Senior Associate, R&D Compliance
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
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