Qualifications

• Bachelor's Degree in a relevant field.
• Knowledge of current GCP regulations.
• Experience with regulatory agency audits.
• Familiarity with Quality Systems for CROs.
• Excellent written and verbal communication skills.
• Proficiency in MS Office.

Responsibilities

• Support maintenance of the Quality Management System.
• Handle QA training program and document control.
• Oversee customer complaint program and CAPA program.
• Assist with audits of clinical sites and vendors.
• Support internal audit programs and performance metrics for improvement.
• Manage the review cycle of QA controlled documents.
• Provide support during regulatory agency audits.

Benefits

• Full-time employment with a focus on quality assurance.
• Opportunity to work in a dynamic regulatory environment.
• Potential for travel (up to 25%).
• Engagement in continuous improvement initiatives.
• Commitment to diversity in the workplace.