Description
PURPOSE:- To work with and on behalf of CTPQ/CQM within DevOps, performing Qualifying Quality Issue (QQI) management.
- QQI Lead: the individual responsible (from Clinical Quality Mgmt (CQM) or other qualified role) for the formation and leading of the QQI Team and coordinating all activities related to assessing significance, initiating immediate action, conducting RCA, developing preventive and corrective actions, as needed, and documenting case activities within appropriate database.
- Conduct broader impacts across the portfolio to share learning 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 QQI Teams and/or RCA Teams, progress delivery of actions,
- Understanding/knowledge of: GCP, clinical trial processes and systems, CAPA, quality issues, Root Cause Analysis, regulatory requirements, quality management, inspection readiness
- QQI management
- Determine significance of the QQI (with team), follow-up as needed
- Arranging meetings with QQI Team, RCA Team, and/or Business Process Owner within timelines specified
- Documenting meeting outcomes in meeting minutes or other
- Facilitating Root Cause Analysis and producing outputs
- Ensuring appropriate actions assigned and progressed to completion
- Updating the appropriate database
- Ensuring all documentation is filed appropriately
EDUCATION:
- 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
- Quality related experience including familiarity with:
- ICH GCP, and Regulatory obligations
- Quality and compliance management, QC
- Project/initiative coordination and management skills
- Root Cause Analysis
- Experienced in Quality areas: eg audit, inspection, compliance, CAPA management, and inspection readiness fields
- Project Management skills/experience
- 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
- Ability to translate quality/compliance strategic imperatives into executable tactical plans
- Acts independently.
- Most projects are self initiated.
- Leverages knowledge from others related to overall objectives, strategy, critical issues, and policy matters.
- Having the personal and organizational confidence to communicate difficult messages promptly and in a suitable manner so that appropriate actions can be taken.
- Encourages contributions by generating commitment to and achievement of business objectives; serves as an advocate for others.
- MS Word