Staff, Clinical Quality Assurance (CQA), R&D Quality

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タケダの紹介

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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

• 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 managers 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:

• 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.