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.

• 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

• 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\

Thanks

Warm Regards

Ricky Bansal

732-429-1925