Quality by Design (QbD)/Quality Risk Management:
• Lead teams for each new study to identify factors (processes and data) that are critical to quality and to proactively identify, prioritize, and manage important risks to quality.
• Ensure that operational feasibility and patient engagement insights are integrated into QbD/quality risk management activities and the associated clinical study protocol.
• Lead teams to identify study level quality tolerance limits (QTLs), set proper thresholds, and consistently oversee and manage performance.
• Ensure proper QTL oversight at a portfolio level.
• Perform oversight to ensure that quality risk management plans are promptly implemented and routinely updated, specifically in response to protocol amendments, quality issues, and audit/inspection findings.
• Design and implement method to drive portfolio/program level quality risk management.
• Partner with CROs to ensure that internally driven quality risk assessments are seamlessly integrated into CRO plans and improved based on CRO input.
• Create and maintain risk library, using complete quality data (incl from external sources) for insights.
• As the subject matter expert for risk-based monitoring/study management, support study teams to decide the best strategy/approach for monitoring (considering effectiveness and efficiency), ensuring it is consistently focused on critical to quality factors (data and processes) in relation to level of risk (specifically oversee SVR / % SDV and associated rationale)
• Review proposed initial site tiering to ensure available quality information is supportive.
• Support review and response to key risk indicators (KRIs), including changes to site tiering.
• Partner with other units to ensure that data collection and analytics supply best information to focus monitoring/oversight.
• Partner with other units to ensure sponsor oversight activities focus on critical processes/data and is appropriately documented.
• Support and oversee study teams to ensure that inspection readiness tools are consistently and appropriately maintained.
• Guide study teams to develop fit for purpose storyboards for key issues experienced(proactively).
• Partner with RDQ to co-lead inspection preparation activities for cross-functional study teams
• Support and oversee appropriate 3rd Party oversight by study teams.
Business Process Management:
• Lead execution and oversight of business process management for ‘Perform Clinical Drug Development’ ensuring appropriate definition, elaboration, integration, documentation, measurement, and continuous improvement for associated processes
.• Ensure process metric dashboards are created and routinely used to facilitate process oversight.
• Develop and implement plans to build and sustain process-oriented management strategy/culture with BPO role as the focal point.
• Provide BPO support and oversight for applicable processes (such as Clinical Study Quality Risk Management, Clinical Study Monitoring, and Inspection Readiness).
Local/Regional Quality Leadership:
• Lead local office/regional staff to implement clinical quality management principles, proactively identify and manage quality risks/issues, prepare for audits and inspections and correct/prevent findings, as appropriate, and consistently comply with global regulatory requirements with a specific focus on local studies for the local market.
• Contribute to global Clinical Quality Management (CQM) and/or Strategic Business and Development Operations (SBDO) initiatives and ensure global practices are followed appropriately in local environments.
• Oversee local archiving activities, working with teams and CTE Enabling Services Archiving Lead on local and global needs.
• Proactively identify and propose training needs for local/regional SBDO regarding new or revised quality standards and documents
General Operational Quality Support:
• Support/consult with colleagues and teams to provide first-level guidance on quality related issues and processes.
• Partner closely with stakeholders to ensure that quality improvement actions (in response to quality issues and audit/inspection findings) are operationally feasible and commensurate with the level of risk (e.g., fit for purpose)
• Interface with RDQ to maintain ongoing visibility into and to potentially influence audit plans/strategy
• Review quality issue and audit/inspection CAPAs to ensure suitability
• Meet regularly with QSLs to align on quality issues and priorities
• Implement predictive analytics with focus on quality (sites, data, processes)
• Participate in quality governance (if any)
1. Strong understanding of Quality by Design principles, clinical quality risk management processes, risk-based monitoring, and trial oversight as required by ICH E6 R2.
2. Proficient in verbal and written English and Japanese.
3. Uses appropriate interpersonal styles and techniques to influence people from a variety of ethnic, social and educational backgrounds and drive change; able to size up situations quickly; able to identify common interests; facilitates resolution.
4. Ability to balance competing priorities of various stakeholders and strive for achieving mutually beneficial and compliant solutions.
5. Record of successful vendor interactions.
6. Strong knowledge management, project management and change management skills.
7. Strong data insights and analytical skills to identify trends and drive quality / process improvements.
8. Ability to make risk-based decisions based on a robust benefit/risk assessment.
9. Ability to lead GCP inspection readiness activities and support global health authority inspections.
10.Acts as GCP/risk-based quality management Subject Matter Expert for clinical activities.
11.Ability to work in intense, fast paced, matrixed, multinational work environment, fostering collaboration within and across functional areas. 12.Strong understanding of Japanese-specific regulations, including Japan Good Clinical Practice (J-GCP), Good Post-Marketing Study Practices (GPSP) and ability to serve as a subject matter expert to global study teams and the Japan R&D colleagues.
13.Ability to work independently on assigned tasks or projects.
14.Capability to perform self-training.
15.Ability to accept delegatio