Manager Clinical Quality Investigations

4 weeks ago

Cincinnati, United States Medpace Full time

Job Summary

We are looking to strengthen the Global Quality Assurance (QA) team with an experienced QA professional supporting continuous improvement of the Medpace Quality Management System through application of Quality Event Issue Management. This position will preferably be based in one of the US based offices (Cincinnati, Dallas, Denver). Other US East coast locations or a home-based position may be considered too, depending on experience and expertise of the candidate.

Responsibilities

The successful candidate will be responsible for facilitating management of Quality Investigations and identification and evaluation of risks and process improvements through application of the Medpace Quality Event Management (QEM) program. Translating data into knowledge and making best use of knowledge are essential to achieving the Medpace mission of accelerating the global development of safe and effective medical therapeutics.

QEM Program activities

* Deliver high-quality QI investigations, root cause analyses and risk assessments.
* Partner with Management Designees, and operational Subject Matter Experts across all steps of the QEM process to facilitate robust corrective and preventive actions required to prevent recurrence of issues.
* Determine the most appropriate process for investigating and documenting Quality Events as part of triage.
* Provide training on how to conduct Quality Investigations.
* Conduct risk-based, independent Process Walkthroughs as part of QE investigations and root cause analyses.
* Conduct CAPA effectiveness check audits where required.
* Share lessons learned with affected teams through delivery of case study workshops and case study lectures.
* Contribute to the QEM Program through maintaining Controlled Documents, Guidelines, Templates and associated training for Medpace staff.
* Maintain oversight on assignments, timely progression, and completion of QIs through the monitoring of Business Intelligence dashboards.
* Develop executive summaries of significant QIs for senior management, the President, and the CEO.
* Provide support to Medpace QA staff hosting external audits and regulatory inspections by addressing auditors'/inspectors' questions and/or provide QEM expertise.
* Utilize a categorization system and Business Intelligence tool to facilitate identification of process and system level trends and risks across all regulated Medpace Business Entities and Functional Areas (FAs).
* Facilitate reliable and repeatable categorization of QA data.
* Assist in maintaining a data trending and analysis schedule for Medpace core processes.
* Coordinate and perform scheduled or ad hoc reviews of QA data, assess risks (likelihood, impact, detectability) and share actionable insights and recommendations with Medpace stakeholders (e.g. Process Owner, Training and Development, Process Improvement).
* Provide data-driven support to the development of risk-based internal process audit schedules across Medpace Business Entities.
* Provide data-driven support to the development of internal process audit plans and contribute to audit conduct and reporting.

Qualifications

* Bachelor's degree required (a more advanced degree preferred) in science or a related field.
* At least five (5) years of QA experience in a GCP regulated environment (a combination of experience in GxP regulated environment, including GCP will also be considered).
* Experience in problem solving through investigation, root cause analysis and CAPA planning.
* Strong analytical skills.
* Strong quality mindset.
* Excellent written and verbal communications skills in English.
* Independent thinking and planning ability.
* Experience in quality risk management is a plus.
* Experience with a wide range of computerized systems including MS Office (experience with Business Intelligence tools is a plus).
* Good time management skills.
* Ability to switch between both big picture view and attention to detail.
* Ability to develop strong collaborative working relationships with key stakeholders.
* The ability to work well on a team as well as independently.

Location could be any country in EST and CET time zones.

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?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks

* Cincinnati Campus Overview
* Hybrid work-from-home options (dependent upon position and level)
* Competitive PTO packages, starting at 20+ days
* Flexible work hours
* Discounted tuition for UC online programs
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Community involvement with local nonprofit organizations
* Competitive compensation and benefits package
* Structured career paths with opportunities for professional growth
* Partnership and discount with onsite childcare
* Discounts on local sports games, local fitness gyms and attractions
* Official Sponsor of FC Cincinnati


* Modern, ecofriendly campus with an on-site fitness center, bar, and restaurants

Awards

* Recognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023
* Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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