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Form of workJob Summary
We are looking to strengthen the Global Quality Assurance (QA) team with an experienced QA professional supporting continuous improvement of Medpace's Quality Management System through application of Quality Event and Quality Risk Management. This position will preferably be based in one of the US based offices (Cincinnati, Dallas, Denver, Minnesota). Other 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 the management of Quality Events and identification and evaluation of Quality Risks through application of Medpace's Quality Event and Risk Management (QERM) program. Translating data into knowledge and making best use of knowledge are essential to achieving Medpace's mission of accelerating the global development of safe and effective medical therapeutics.
• 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 across Medpace Business Entities 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.
• At least two (2) years of QA experience or at least four (4) years of operational experience in a GCP regulated environment (a combination of experience in GxP regulated environment, including GCP will also be considered). Position level will be determined based on experience of the candidate.
• 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.
• 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?
People. Purpose. Passion. Make a Difference Tomorrow. Join 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.
Medpace Celebrates 30 Years
As we celebrate 3 decades of industry expertise and organic growth, we recognize the global team responsible for driving clinical development at Medpace. Click here to learn more about Medpace Celebrating 30 Years.
Cincinnati Perks
Awards:
What to Expect Next:
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
We are looking to strengthen the Global Quality Assurance (QA) team with an experienced QA professional supporting continuous improvement of Medpace's Quality Management System through application of Quality Event and Quality Risk Management. This position will preferably be based in one of the US based offices (Cincinnati, Dallas, Denver, Minnesota). Other 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 the management of Quality Events and identification and evaluation of Quality Risks through application of Medpace's Quality Event and Risk Management (QERM) program. Translating data into knowledge and making best use of knowledge are essential to achieving Medpace's mission of accelerating the global development of safe and effective medical therapeutics.
• 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 across Medpace Business Entities 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.
• At least two (2) years of QA experience or at least four (4) years of operational experience in a GCP regulated environment (a combination of experience in GxP regulated environment, including GCP will also be considered). Position level will be determined based on experience of the candidate.
• 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.
• 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?
People. Purpose. Passion. Make a Difference Tomorrow. Join 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.
Medpace Celebrates 30 Years
As we celebrate 3 decades of industry expertise and organic growth, we recognize the global team responsible for driving clinical development at Medpace. Click here to learn more about Medpace Celebrating 30 Years.
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 and 2022
- 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.
