Description
Purpose:
To work with and on behalf of CTPQ/GCP Compliance Management within DevOps, performing management Significant Quality Events.
Significant Quality Event Lead:
The individual will be 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 learning with other impacted study teams.
This position will include:
1. Interaction with a diverse range of stakeholders from varying internal lines
2. Ability to be an effective project manager, leadership of Significant Quality Event Teams and/or Investigation/RCA Teams, progress delivery of actions
3. Understanding/knowledge of GCP, clinical trial processes and systems, CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, inspection readiness
Primary Duties:
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
SKILLS:
Training and Education Preferred:
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.
Prior Experience Preferred:
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
Technical Competencies:
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