Quality Lead

• 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