Global QA Auditor & Quality Program Lead - Clinical Trials

Medpace; Cincinnati (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

PTO

WFH flexibility after training

Social events

Job summary

Medpace is seeking an experienced QA Auditor to support and audit global trials, ensuring compliance with GCP and regulatory standards. The role focuses on auditing vendors and investigative sites, coordinating internal system audits, and contributing to SOP development within the Quality Assurance department.

The ideal candidate has a life sciences degree and 2–5 years of QA experience, with strong communication, teamwork, and independent work capabilities.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 2–5 years of experience in a QA department in a related industry.
• Experience conducting audits of vendors and investigative sites.

Responsibilities

• Act as a Quality Program Lead on clinical trials by supporting national and international regulatory standards and guidance for pharmaceuticals, biologics and medical devices.
• Develop audit management plans and audit strategy with clients for ongoing clinical trials.
• Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines.
• Participate in the development of departmental standard operating procedures, work instructions, forms, and templates.
• Assess validated state and security of proprietary and cloud based software.
• Develop training materials and applicable interactive tests and proficiency training including company-wide regulatory training (ICH/GCP).

Skills

QA audits

GCP knowledge

Regulatory standards

Vendor/site audits

Travel up to 40%

Communication

Teamwork

Independent work

Education

Bachelor’s degree in life sciences or related field

Job description

Medpace is seeking an experienced QA Auditor to support and audit global trials, ensuring compliance with GCP and regulatory standards. The role focuses on auditing vendors and investigative sites, coordinating internal system audits, and contributing to SOP development within the Quality Assurance department.

The ideal candidate has a life sciences degree and 2–5 years of QA experience, with strong communication, teamwork, and independent work capabilities.