Quality Lead

Quality Lead

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

To work with and on behalf of CTPQ/GCP Compliance Management within DevOps, performing management Significant Quality Events.

Significant Quality Event Lead: the individual responsible for the formation and leading of the Significant Quality Event Team and coordinating all activities related initiating immediate action, conducting Investigation/RCA, developing corrective and preventive actions, as needed, and documenting case activities within appropriate database

Conduct broader impacts across the portfolio to share learnings with other impacted study teams.

Interaction with: A diverse range of stakeholders from varying internal lines

Ability to: be an effective project manager, leadership of Significant Quality Event Teams and/or Investigation/RCA Teams, progress delivery of actions

Understanding/knowledge of: GCP, clinical trial processes and systems, CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, inspection readiness

Significant Quality Event management

Forming Significant Quality Event Team

Arranging meetings with Significant Quality Event Team, RCA Team, and/or Business Process Owner within timelines specified

Documenting meeting outcomes in meeting minutes or other

Facilitating Root Cause Analysis (or other types of investigation) and producing outputs

Ensuring appropriate actions assigned and progressed to completion

Updating the appropriate database

Ensuring all documentation is filed appropriately

Qualifications

Degree in one of the disciplines related to drug development or business

Advanced/in-depth knowledge which may include quality audit, quality management, inspection readiness, quality and compliance assessments, CAPA Management, continuous improvement methodology, root cause analysis

Knowledge of clinical trials operational processes and systems which may include study management, data management, reporting, and project management

Understanding of clinical trials

Ability to work successfully with internal and external partners; strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organization

Experience of leading global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries

Knowledge of quality requirements across a range of different countries

Strong influencing skills with ability to influence a broad range of global stakeholders

Excellent communication skills adaptable to meet the needs of diverse stakeholder groups, internal and external

Record of achievement and delivery for personal and team goals

Ability to balance and prioritize a diverse and demanding workload

Works independently and proactively set own work agenda with minimum guidance

Familiarity with ICH GCP, and Regulatory obligations

Quality and compliance management, QC

Project/initiative coordination and management skills

Root Cause Analysis

CI/RCA skill and experience

Knowledge of ICH GCP and regulations in order to assess GCP situations and appropriate actions

Ability to lead cross-line global initiatives or root cause analysis for quality related process improvement