A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
The Clinical Quality Management Lead Japan serves as the Japan go-to Clinical Quality Management expert for study teams and for R & D Japan.
Report to: Line Manager in Japan
Direct reports: 0. (Single Contributor)
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.
Risk-Based Monitoring / Overseas
- 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.
Inspection Readiness / Preparation
- 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 (eg, 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)
Job Requirements: * Strong understanding of Quality by Design principles, clinical quality risk management processes, risk-based monitoring, and trial oversight as required by ICH E6 R2.
- Proficient in verbal and written English and Japanese.
- 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.
- Ability to balance competing priorities of various stakeholders and strive for achieving mutually beneficial and compliant solutions.
- Record of successful vendor interactions.
- Strong knowledge management, project management and change management skills.
- Strong data insights and analytical skills to identify trends and drive quality / process improvements.
- Ability to make risk-based decisions based on a robust benefit / risk assessment.
- Ability to lead GCP inspection readiness activities and support global health authority inspections.
- Acts as GCP / risk-based quality management Subject Matter Expert for clinical activities.
- Ability to work in intense, fast paced, matrixed, multinational work environment, fostering collaboration within and across functional areas.
- 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 Biopharma Japan R & D colleagues.
- Ability to work independently on assigned tasks or projects.
- Capability to perform self-training.
- Ability to accept delegatio
Recruiting contact: Fang Liu
We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your Join us and bring your curiosity to life! Own career map that is responsive to your aspirations and priorities in life!
Curious? Apply and find more information at https://jobs.vibrantm.com
Job Requisition ID: 218986
Career Level: E –Professional (10+ years)
Working time model: full-time
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00 am to 5:30 pm ET Monday through Friday.