Clinical Laboratory Quality

il y a 3 semaines


Leuven, Belgique Medpace, Inc. Temps plein

Job Summary:
Responsibilities:

- Supporting Medpace’s Quality Event Management (QEM) program through triage, and facilitating QEM steps such as problem definition, investigation, root cause analysis, CAPA planning and CAPA effectiveness driving continuous improvement of Quality Management System.
- Supporting further development systems, and tools to gather, organize, visualize, trend, and analyze data resulting from Sponsor Audits, Regulatory Inspections, Medpace Audits (Investigator Site, Vendor, Internal Process) and QEM Program and relevant external data sources.
- Developing and maintaining Quality Metrics to facilitate identification of potential trends and risks and providing actionable insights and recommendations to Process Owners and training and development teams.
- Leveraging risks at level of process / system to support proactive improvement of GxP regulated processes and systems and informing Medpace’s audit strategy and schedules.
- Supporting Process Owners with management of operational risks, including but not limited to risk identification, evaluation, control and/or monitoring strategies.
- Monitoring the effectiveness of CAPA and risk mitigation plans through internal process audits.
- Disseminating knowledge to Medpace stakeholders through training and education.
- Supporting maintenance and development of a risk-based Quality Management System, including creation, revision, or periodic review of Standard Operating Procedures.

Qualifications:

- Bachelor’s degree required (a more advanced degree preferred) in science or a related field.
- Experience in problem solving through investigation, root cause analysis and CAPA planning.
- Experience in Quality Risk Management is a plus.
- Strong analytical skills.
- Strong quality mindset.
- Excellent written and verbal communications skills in English. Fluency in Dutch is a plus.
- Independent thinking and planning ability.
- 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.

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
- Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati

**What to Expect Next**:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
- EO/AA Employer M/F/Disability/Vets_


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