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.