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Staff, Clinical Quality Assurance （CQA）

年収： 1000万～ 1200万

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部署・役職名	Staff, Clinical Quality Assurance （CQA）
職種	臨床開発 CRA（臨床開発モニター） GCP・GLP監査
業種	医薬品メーカー CRO
勤務地	大阪府
仕事内容	【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.
労働条件	【勤務地】大阪本社：大阪市中央区道修町四丁目1番１号【待遇】諸手当：通勤交通費、借家補助費、勤務時間外手当など昇給：原則年1回　賞与: 原則年2回勤務時間：大阪本社：9:00～17:30（休憩45分）休日：土曜、日曜、祝日、メーデー、年末年始など（年間123日程度）働き方関連制度：フレックスタイム制、テレワーク勤務制導入休暇：年次有給休暇、特別有給休暇、傷病休暇、ファミリーサポート休暇、産前産後休暇、育児休暇、子の看護休暇、介護休暇【労働条件に関する重要事項】業務内容については入社後に会社の定める業務への変更もあり得ます。配属先および就業場所に関しては、入社後に会社の定める部署および就業場所への変更もあり得ます。
応募資格	【必須（MUST）】【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).
アピールポイント	自社サービス・製品あり日系グローバル企業女性管理職実績あり上場企業従業員数1000人以上創立30年以上年間休日120日以上産休・育休取得実績ありストックオプション制度あり教育・研修制度充実資格支援制度充実フレックスタイム
リモートワーク	可「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります
受動喫煙対策	屋内禁煙
更新日	2026/06/18
求人番号	8688344

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武田薬品工業株式会社

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