Manager Clinical Quality Investigations - Medpace, Inc.
Cincinnati, OH
About the Job
Manager Clinical Quality Investigations
Job Locations
United States-OH-Cincinnati
Category
Quality Assurance
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 pl
Job Locations
United States-OH-Cincinnati
Category
Quality Assurance
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 pl
Source : Medpace, Inc.