Job Description

Job Summary

We are currently seeking a Quality Assurance Manager to join our team. You will manage QA Auditors, as well as aspects of projects, investigative site audits and/or business segments as needed. You will develop and oversee employee training. You will also help plan and maintain the annual audit schedule in conjunction with Department Director, including proposing and developing audit plans for new projects. You will work directly with the Clients, as needed.

Responsibilities

• Independently coordinate the conduct of all types of audits and ensure completion of QA department responsibilities identified by SOPs;
• Oversee and manage auditor capacity planning and audit reporting requirements per procedure;
• Provide line management responsibilities and development for multiple QA Auditors;
• Assisting the QA Director with coordinating and conducting internal system audits and external vendor audits for central laboratory and CRO operational functions;
• Participate in audits by Sponsors and/or Regulatory Inspectors;
• Identify areas of risk and provide input on an effective QA oversight plan to mitigate the identified risk;
• Proactively identify and resolve non-compliance issues within Medpace lines of business;
• Create and revise departmental SOPs and guidelines; and
• Other items as deemed necessary.

Qualifications

• A Bachelor`s degree, preferably in Life Sciences;
• Previous experience in a QA role, within a CRO or pharmaceutical setting is preferred;
• Ability to manage a risk-based approach to the planning and scheduling of all audit types on a company-wide basis;
• Previous experience overseeing and managing auditor capacity planning and audit reporting;
• Line management experience;
• Experience in Regulatory inspections and interacting with Sponsor/client representatives; and
• Knowledge and application of GCP and GLP.

Medpace Overview

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.

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

Awards:

• Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
• Recognized by Forbes as one of America\'s Best Mid-size Companies in 2021
• Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

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*WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.

Medpace