Integrated Resources Inc.
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-state area's most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since 1996. Our mission centers on delivering top-quality talent, the first time and every time. We provide resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing.
A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Job Description - Collaborate with and support CTPQ/GCP Compliance Management within DevOps, focusing on managing Significant Quality Events.
- Lead the Significant Quality Event team, coordinating activities such as immediate action, investigation/RCA, corrective and preventive actions, and documentation within the appropriate database.
- Share learnings across the portfolio to other impacted study teams.
- Interact with a diverse range of internal stakeholders.
- Effectively manage projects, lead Significant Quality Event and Investigation/RCA teams, and ensure timely delivery of actions.
- Possess knowledge of GCP, clinical trial processes and systems, CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, and inspection readiness.
- Manage Significant Quality Events, including forming teams, arranging meetings, documenting outcomes, facilitating investigations, and ensuring follow-up actions are completed and documented properly.
Qualifications - Degree in a discipline related to drug development or business.
- In-depth knowledge of quality audit, quality management, inspection readiness, compliance assessments, CAPA management, continuous improvement, and root cause analysis.
- Knowledge of clinical trial operational processes, including study management, data management, reporting, and project management.
- Understanding of clinical trials and ability to work effectively with internal and external partners.
- Experience leading global initiatives or project teams, with awareness of regulatory requirements across different countries.
- Knowledge of international quality standards and requirements.
- Strong influencing and communication skills, capable of engaging diverse stakeholder groups.
- Proven achievement in personal and team goal delivery.
- Ability to prioritize and manage a demanding workload independently.
- Familiarity with ICH GCP and regulatory obligations.
- Skills in quality and compliance management, project coordination, CI/RCA.
- Ability to lead cross-line global initiatives and root cause analyses for process improvements.
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A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Job Description - Collaborate with and support CTPQ/GCP Compliance Management within DevOps, focusing on managing Significant Quality Events.
- Lead the Significant Quality Event team, coordinating activities such as immediate action, investigation/RCA, corrective and preventive actions, and documentation within the appropriate database.
- Share learnings across the portfolio to other impacted study teams.
- Interact with a diverse range of internal stakeholders.
- Effectively manage projects, lead Significant Quality Event and Investigation/RCA teams, and ensure timely delivery of actions.
- Possess knowledge of GCP, clinical trial processes and systems, CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, and inspection readiness.
- Manage Significant Quality Events, including forming teams, arranging meetings, documenting outcomes, facilitating investigations, and ensuring follow-up actions are completed and documented properly.
Qualifications - Degree in a discipline related to drug development or business.
- In-depth knowledge of quality audit, quality management, inspection readiness, compliance assessments, CAPA management, continuous improvement, and root cause analysis.
- Knowledge of clinical trial operational processes, including study management, data management, reporting, and project management.
- Understanding of clinical trials and ability to work effectively with internal and external partners.
- Experience leading global initiatives or project teams, with awareness of regulatory requirements across different countries.
- Knowledge of international quality standards and requirements.
- Strong influencing and communication skills, capable of engaging diverse stakeholder groups.
- Proven achievement in personal and team goal delivery.
- Ability to prioritize and manage a demanding workload independently.
- Familiarity with ICH GCP and regulatory obligations.
- Skills in quality and compliance management, project coordination, CI/RCA.
- Ability to lead cross-line global initiatives and root cause analyses for process improvements.
#J-18808-Ljbffr