Associate Director, Clinical Quality Assurance (CQA), TDC-J

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Job Description

タケダの紹介

タケダでは常に患者さんを中心に考え世界中の人々により健やかで輝かしい未来をお届けすることを目指してきましたそして従業員一人ひとりにそれぞれの能力と熱意に応じた成長の機会を提供することにも組んで取り組んでいます私たちと一緒に世界中の人々のいのちに貢献しさらなる成長と活躍を目指しませんか

タケダは国内第一の製薬企業そして業界を牽引するグローバルリーダーです従業員は四つの優先順位患者さん中心社会との信頼関係構築レピュテーションの向上事業の発展とタケダイズム誠実公正正直不屈のもと一致団結していますタケダイズムは私たちの信念であり正しい方向へ導く羅針盤です私たちは日々の業務においてタケダイズムを体現しています

Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do we continue to innovate and drive changes that will better their lives - were looking for like-minded professionals to join us.

Takeda is the number one pharmaceutical company in Japan and a global industry leader we are united by our four priorities (Patients Trust Reputation and Business) and our shared values ofTakeda-ism: Integrity Fairness Honesty and Perseverance. Takeda-ism is more than just a word. Its a belief and a mindset which guides our decisions behaviors and interactions. Its how we strive to work and live every day.

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 Takedas 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.

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS

• BA/BS degree required; advanced degree preferred.
• Minimum of 10 years of experience in the pharmaceutical biotechnology or related health care industry.
• Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
• Minimum 5 years leading teams in a matrix cross-functional team.
• Languages: Japanese (native level) English (business level).

タケダのDEI

Better Health Brighter Future

Takeda Compensation and Benefits Summary:

• 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.

Important Notice concerning working conditions:

• It is possible the job scope may change at the companys discretion.

• It is possible the department and workplace may change at the companys discretion.

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