Quality Lead

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. 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