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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 - we’re 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 of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. Takeda-ism is more than just a word. It’s a belief and a mindset which guides our decisions, behaviors, and interactions. It’s how we strive to work and live, every day.
OBJECTIVES/PURPOSE
- Lead and execute Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including audits, quality issue management, investigations, and inspection support.
- Lead or support PMDA inspection readiness for assigned studies, including end-to-end preparation, inspection management, and response coordination, while leveraging guidance from experienced colleagues or manager as appropriate.
- Provide expert guidance on GCP and applicable regulations, driving proactive quality risk management to support pipeline success and timely delivery of therapies to patients.
- Drive consistent quality across programs by establishing risk-based audit and compliance strategies and enabling sustainable inspection readiness.
ACCOUNTABILITIES
- Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams, through proactive risk management and QA activities.
- Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases or vendors in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and may involve technically complex assignments.
- Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management.
- Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
- Facilitate investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
- Lead or support GCP health authority inspections in collaboration with relevant functions; support clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate and timely inspection responses and follow-up actions.
- Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.
- Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution.
CORE ELEMENTS RELATED TO THIS ROLE
・Establish credibility and act responsibly to earn the confidence, trust and respect of others.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BA/BS degree required; advanced degree preferred.
- Minimum of 3 years of experience in the pharmaceutical, biotechnology or related health care industry.
- Minimum 1 year of GCP-related Quality Assurance or relevant clinical trial experience.
- Strong analytical, communication, and cross-functional coordination skills, including the ability to communicate effectively in English and collaborate with global stakeholders (TOEIC score of 800 or above is desirable).
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Strong knowledge of ICH-GCP and Japan regulatory requirements, including PMDA inspection expectations.
- Prior experience in auditing and inspection management, as well as regulatory response coordination, is preferred
- Strong technical writing skills (audit reports, procedures, regulatory responses)
Leadership
- Lead cross-functional teams in a matrix environment without direct authority
- Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams.
- Lead or support GCP health authority inspections in collaboration with relevant functions.
Interaction
- Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.
- Address conflict openly and honestly with team members by seeking common ground and cooperative solutions.
- Fluent in written and spoken English to interact with the global stakeholders.
Innovation
- Strong judgment, project management and decision-making skills.
- Manage multiple priorities and timelines effectively.
- Seek advice from his/her supervisor or other experienced persons in inexperienced and/or unknown cases.
Complexity
- Superior attention to detail and ability to analyze complex data
- Prepare and execute work plans to achieve the goals of the organization based on own experiences, precedents or support from others if needed.
Decision-making and Autonomy
- Responsible for conducting Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and experience in GCP and compliance, communication skills, and business acumen to conduct responsibilities with minimal supervision.
- Decide what to do and how to do within the scope of manager’s roles and responsibilities.
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:
Locations
Osaka, Japan
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
