仕事内容 | 【OBJECTIVES/PURPOSE】
・Provides leadership and guidance to the CQA Program Managers and partner with key stakeholders that are integral to clinical development activities, as applicable.
・Contributes to the design and implementation of Takeda’s risk-based GCP audit and compliance oversight activities.
・Monitors effectiveness of GCP processes through risk-based audits and GCP compliance activities and provide actionable data to Senior Management based on identified compliance issues and trends.
・Oversees and provides necessary support for the GCP components of egulatory Inspections.
【ACCOUNTABILITIES】
・Provides leadership and guidance to the CQA Program Managers to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required are maintained in compliance with applicable regulations, as applicable.
・Provides ongoing development of the CQA Program Managers, including staff selection, work assignments, goal completion, development plan review, and performance management, as applicable.
・Establishes strong partnership/relationship with business stakeholders
・Develops and implements a strategic audit plan in collaboration with Global CQA Leaders.
・Ensures audit observation, report, and rating consistency for assigned area of responsibility.
Ensures activities are conducted and reports written according to applicable SOPs and regulations.
・Acts as a quality resource with expertise in regulations relating to GCP, ICH guidelines, and Development Operations SOPs.
・Responsible for the CQA due diligence for new compounds/alliances for Quality, in collaboration with senior management in QA.
・Manages Therapeutic Area Programs of a highly complex nature and/or high-risk programs including, multiple indications, data safety monitoring boards, endpoint review committees as well as those requiring the coordination of multiple “niche” vendors
・Monitors and interprets compliance issues identified across clinical programs and elevates systemic problems with appropriate recommendations/solutions to CQA management for immediate and long-term resolution across Takeda R&D.
・Provides appropriate risk analysis for key stakeholders to make critical decisions.
・Represents Takeda R&D during GCP regulatory inspections assuring management that responses are timely and appropriate to maintain good standing with regulatory agencies.
・Coaches and educates external sites and cross functional Takeda R&D staff in regulatory inspection readiness activities.
【CORE ELEMENTS RELATED TO THIS ROLE】
・Provides team members with timely, constructive feedback, coaching and support to help them recognize and take action on their strengths and development needs in unprecedented, complicated and challenging projects such as new disease areas and new therapies.
【DIMENSIONS AND ASPECTS】
◎Technical/Functional (Line) Expertise
・Advanced knowledge and experiences in drug development process, and its horizontal expansion to unprecedented, complicated and challenging projects such as new disease areas and new therapies.
・Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development.
・Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
・Strong technical writing skills; able to write quality positions, audit reports, and procedures.
◎Leadership
・Provides strategic leadership to the Clinical Quality Assurance (CQA) Program Managers even in case of never experienced therapeutic areas or new modalities, and partner with key stakeholders that are integral to clinical development activities, as applicable.
・Provides expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program cross-functional teams and leadership, especially in unprecedented, complicated and challenging projects such as new disease areas and new therapies.
・Provides opportunities to develop others’ technical/functional skills and behaviors.
・Negotiates and influences without authority in a matrix environment.
◎Interaction
・Collaborates with and achieves results through R&D operational functions and suppliers of outsourced services in order to build win-win relationships with broad ranges of stakeholders.
・Engages diverse team members with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.
・Fluent in written and spoken English to interact with the global stakeholders.
◎Innovation
・Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.
・As deputy for a CQA Director (based on delegation), motivates Japan CQA employees to innovate on past practices.
・In collaboration with a CQA Director, reveals the root of the problem and to improve the current existing processes/concepts by encouraging Japan CQA employees.
・In collaboration with a CQA Director, establishes the environment where employees grow through challenging assignments so they may realize their full potential.
◎Complexity
・Superior attention to detail and ability to analyze complex data under the unprecedented, more complicated and challenging circumstances.
・In case of challenging situations such as new therapeutic areas or new modalities, sets the direction and creates solutions even if there are no answers or hints based on own experiences.
・Deep insight of how to encourage others from the perspective of people management in challenging projects such as new therapeutic areas or new modalities.
◎Decision-making and Autonomy
・Focuses people on key priorities and guides them to achieve their goals and helps employees grow through challenging assignments so they may realize their full potential with full autonomy in collaboration with a CQA Director.
・As deputy for a CQA Director (based on delegation), creates and implements regional strategy in line with global strategic objectives and in collaboration with R&D Quality, R&D operational functions, and suppliers of outsourced services to ensure that clinical trial activities sponsored by Takeda are conducted in compliance with local regulations, Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda requirements.
・As deputy for a CQA Director (based on delegation), provides strategic direction and manages health authority GCP sponsor and investigator routine and pre-approval inspection readiness, conducts, and follow-ups activities for development programs in Japan, ensuring that GCP inspection commitments are fulfilled on time.
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待遇・福利厚生 | ・社会保険完備
・独身寮・社宅
・財産形成：従業員持株会、財形貯蓄、住宅融資、企業年金制度
・保養所（全国各地）
・人材育成支援制度
・テレワーク勤務制導入（対象社員）
・Allowances: Commutation, Housing, Overtime Work etc.
・Salary Increase: Annually, Bonus Payment: Twice a year
・Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
・Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
・Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
・Flexible Work Styles: Flextime, Telework
・Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc. |
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