Laboratory Quality Assurance (QA) Manager

• Manage Internal and External Laboratory related Audits according to current applicable Regulations;
• Coordinate, conduct and track company-wide Regulatory training and Quality Event Management;
• Management and oversight of departmental Standard Operating Procedures, forms and templates;
• Host Audits/Inspections by Sponsors and Regulatory Inspectors in a Clinical Lab setting;
• Conduct vendor audits;
• Coordinating, conducting, and tracking Regulatory Training (GLP and ICH/GCP) on a company wide basis;
• Supervise QA Lab Auditors and Associates;
• Assisting QA leadership with departmental overview and development of QA Auditors; and
• Developing training materials and applicable tests and guides.

• Bachelor’s degree in Life Sciences or a related field;
• 3 - 5 years of experience in a lab setting in a related industry required;
• Knowledge and application of GCP and GLP is required;
• Past supervisory experience is preferred;
• Experience in conducting audits of vendors;
• Experience in hosting Regulatory Authorities and interacting with Sponsor/client representatives;
• Independent thinking and planning ability; and
• Excellent written and verbal communication skills.

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.