Quality Assurance (QA) Associate

About the Role

Medpace is seeking a professional to facilitate the management of sponsor audits, a broad range of regulatory inspections (FDA, EMA, MHRA), and QA relationships with external clients. The role includes conducting inspection readiness activities for Medpace and its stakeholders.

Responsibilities

• Facilitate Medpace sponsor audits onsite.
• Review and assess responses to sponsor audit reports.
• Provide clarity to the Quality Management System (QMS) during sponsor audits and other external audits.
• Guide Medpace study teams during sponsor audits.
• Manage pre-inspection activities for Medpace inspections.
• Provide inspection data trends to the Quality Metrics group for executive management review.
• Manage the inspection backroom during regulatory inspections to facilitate the timely delivery of requested documents.
• Conduct mock interviews for subject matter experts (SMEs) during inspection preparation.
• Review and analyze regulatory inspection data issued by regulatory authorities (e.g., MHRA, EMA, FDA).
• Manage training for Medpace stakeholders with respect to inspection readiness.
• Conduct inspection readiness visits at selected sites to assess inspection risk.
• Act as QA lead for inspections at Medpace.
• Provide support for inspections at Medpace external clients (sponsors and investigator sites) as needed.
• Maintain the memorializing of frequently asked questions repository for regulatory inspection.

Requirements

• Bachelor’s degree in science or a related field.
• Experience in conducting and supporting regulatory inspections (FDA, MHRA, and EMA) is a plus.
• Strong communication skills and a quality mindset.
• Experience in supporting or conducting audits.
• Excellent written and verbal communication skills in English.
• Independent thinking and planning ability.
• Experience with a wide range of computerized systems.
• Good time management skills.
• Ability to switch between both big-picture view and attention to detail.
• Ability to work well on a team as well as independently.

About Medpace

Medpace is a full-service clinical contract research organization (CRO) providing 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Benefits

• Competitive compensation programs that recognize and reward performance.
• Comprehensive health, wellness, retirement, and PTO benefits.
• Office-based culture with occasional work-from-home flexibility for eligible positions after training.
• Company-sponsored social events and intramural sports.
• Modern corporate campus designed to support collaboration and productivity.
• Multiple on-site dining options in the heart of Madison Square.
• Free on-site parking.
• Convenient access to on-site 24-7 fitness and wellness facilities.

Career Growth & Development

• Purpose-driven work alongside physicians, scientists, and industry-leading experts.
• Collaborative culture with open communication and mutual trust.
• Accessible and approachable leadership throughout Medpace.
• Defined career paths with clear advancement opportunities.
• Industry-renowned onboarding and training programs.
• Ongoing training and continuous learning opportunities.
• Environment that encourages employees to influence change and contribute ideas.