Manager Clinical Quality
Il y a 7 mois
Job Summary:
Responsibilities:
**QEM Program activities**
- Oversee and administer the QEM Program through maintaining Controlled Documents, Guidelines, Templates and associated training for Medpace staff
- Develop and maintain a proficient, user-friendly QEM system
- Provide training to QERM Office team members i.e. Clinical Quality and Risk Management Analysts
- Partner with Management Designees, and operational Subject Matter Experts across all steps of the QEM process
- Determine most appropriate process for investigating and documenting Quality Events as part of triage
- Support high-quality QI investigations, cause analyses and risk assessments and determine need and robustness of corrective and preventive actions required to prevent recurrence
- 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
- Maintain oversight on assignments, timely progression, and completion of QIs through Business Intelligence dashboards
- Develop executive summaries of significant QIs for senior management, the President, and the CEO
- Provide support to Medpace QA hosting external audits and regulatory inspections by addressing auditors'/inspectors' questions and/or provide QEM expertise
**QRM Program activities**
- Develop and maintain 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)
- Secure reliable and repeatable categorization of QA data
- Develop and maintain a data trending and analysis schedule for Medpace's 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)
- Contribute to cross functional study specific protocol evaluation (risk identification) meetings and risk mitigation strategies
- 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
- Support Process Owners with revision of regulated Controlled Documents through sharing relevant QA data and while emphasizing efficiency and effectiveness of the Medpace QMS
- Provide support to Medpace QA staff hosting Sponsor Audits and Regulatory Inspections by addressing questions and providing QRM expertise
- Develop and maintain Business Intelligence dashboards for QA data enabling in-stream operational and quality oversight for both operational and QA staff
- Maintain and improve QRM related Controlled Documents, Guidelines and templates
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.
- 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?:
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
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