Quality Assurance (QA) Associate

Job Summary

The successful candidate will be responsible for facilitating the management of sponsor audits, broad range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities for Medpace and Medpace stakeholders.

Responsibilities

• Facilitating 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;
• Provide guidance to 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;
• Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA);
• Manage training for Medpace stakeholders with respect to inspection readiness;
• Conducting inspection readiness visits at selected sites (as applicable) to assess inspection risk;
• Act as QA lead for inspections at Medpace;
• Provide as needed support for inspections at Medpace external clients (sponsors and investigator sites); and
• Maintain the memorializing of frequently asked questions repository for regulatory inspection.

Qualifications

• Bachelor's degree in Life Sciences or a related field;
• Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA);
• Strong communication skills;
• Strong quality mindset;
• Experience in supporting or conducting audits;
• Excellent written and verbal communications 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; and
• The ability to work well on a team as well as independently.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 all 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.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• • Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• • Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
  • Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• • Office based environment with on-site mentors
  • Defined career paths with clear advancement opportunities
  • Industry renowned onboarding and training programs designed to accelerate professional development
  • Ongoing training and continuous learning opportunities throughout your career
  • An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• • Competitive compensation programs that recognize and reward performance
  • Comprehensive health, wellness, retirement, and PTO benefits
  • Office based culture with occasional WFH that provides flexibility for eligible positions after training
  • Company-sponsored social events and intramural sports

Cincinnati Headquarters Experience

• • A 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

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.