監査の求人一覧

品質保証スペシャリストとして臨床試験におけるGCP、GVPの順守および品質を担保します

仕事内容

The QAS position is responsible for the execution of the global Quality Assurance (QA) audit activities on assigned studies/products/vendors/Country Offices (CO) in the region. This role is responsible for GCP and/or PV oversight, and for assuring the compliance of studies with Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).

Primary activities include but are not limited to:

・Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant business stakeholders (e.g. Clinical trial team), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
・Activities may include GCP and/or PV related routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third party/business partner collaborations and due diligence activities.
・Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
・Promotes standardization of auditing approach within QA.
・May represent QA as a single point of contact and provide QA guidance for studies in a certain Therapeutic Area (TA) or in certain countries to achieve continuous quality improvement and effective quality assurance.
・Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice/Pharmacovigilance QA expertise.
・Contributes to the QA strategy and supports QA goals for the aligned studies/countries in the Region.
・Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
・In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
・In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements) as needed.
・Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as needed.
・Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL, TA Head and line manager.
・Provides inspection management support as appropriate.
・Develops and delivers awareness sessions with minimal supervision on various GCP and/or PV topics internally and externally.
・Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.
・Routinely suggests new audit techniques/aids in areas of technical expertise
・Design and actively participate in special assignments on various project teams and work streams as determined by QA management.
・Provides training and mentorship to less experienced members of QA staff.
・Ensures the work climate/culture within QA, exemplifies leadership behaviors.

応募条件

【必須事項】
・製薬業界でのPV関連の職務経験、またはPV監査のいずれかの経験
・幅広い監査の実施経験を含む、製薬業界での豊富な経験と経験のある方
・ビジネスレベルの英語力
【歓迎経験】
・製薬業界でのGCP監査経験
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京、大阪

年収・給与

600万円～1100万円　経験により応相談

海外駐在！グローバル本社の経営監査部において、日本、欧州、北米、アジアの子会社、部門に対する内部監査業務

仕事内容

グローバル本社の経営監査部において、日本、欧州、北米、アジアの子会社、部門に対する内部監査業務を担当する。
その他、以下の業務についても段階的に担当していただく可能性あり。　　　　　　
・メンバーのマネジメント、人材採用及び育成業務

応募条件

【必須事項】
【業務スキル、経験】
以下のいずれかの経験、スキルを有する者　　
・製薬会社で内部監査を3年以上経験　
・公認内部監査人、内部監査士、公認不正検査士等の内部監査に関わる資格　

【ヒューマンスキル、求める人材像、語学等】
・ グローバル各地域の意見・価値観を受け入れながら、被監査先との事前調整を進めることのできる異文化対応力　【必須要件】
・ 課題の本質を理解し、解決のための提案ができる人材（ロジカルシンキング、文章構造化等のビジネススキルを保有）【必須要件】
・ 社内関係部署との円滑なコミュニケーションを図り、利害調整しながら良好な関係を築くコミュニケーションスキル
・ 内部監査の品質向上及び人材育成に熱意をもって取り組む人材
・ 何事も自ら考え行動することができるプロアクティブな人材

・英語にてインタビューができるレベル【必須要件】
【歓迎経験】
・公認会計士（あるいは論文式試験合格者）
・システムIT能力（CAATs経験）
・海外駐在・出向経験　　等
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

経験により応相談