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

薬機法、公正競争規約、プロモーションコード等の業界規則、その他コンプライアンスポリシーの遵守を担う

仕事内容

・薬機法、公正競争規約、プロモーションコード等の業界規則、その他コンプライアンスポリシーの遵守
・コンプライアンスモニタリングやマテリアルレビュー
・コンプライアンストレーニングの企画・実施
・コンプライアンスリスク管理
・コンプライアンス窓口対応
・調査対応等

応募条件

【必須事項】
・製薬企業での勤務経験
・コンプライアンス関連実務経験
【歓迎経験】
・英語力：Intermediate
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

700万円～900万円　経験により応相談

コンプライアンスビジネスパートナーとの専門的かつ効果的なコラボレーションを維持

仕事内容

・Maintain professional & effective collaboration with Compliance Business Partner including: Meaningful insight to Compliance Business Partners about the status of assurance and any recommendations for improvement plans or corrective action: Timely updates on key incidents/investigations that impact the respective local market: Keeping abreast of local market developments that may impact the state of assurance
・Deliver globally, regionally and locally defined 2nd Line Assurance Plan in line with established time frames
・Record and report all relevant assurance activities in the relevant data repository
・Deliver agreed Assurance reports to Business Partners, Assurance Leads and global in line with agreed timeframes
・Support global and regional Assurance project work
・As required (and at the request of the Business Partner) support discussions at Local Compliance Committee level on Assurance activities and levels of assurance within the market
・As required (and at the request of the Business Partner) provide advice to and consult on effective implementation and maintenance of 1st line monitoring activities
・Perform non-significant compliance investigations and issue reports
・Provide support to Global Investigations Directors for significant investigations
・Ensure prompt communication of all potential investigations to Area Assurance Leads to identify correct path of action
・Maintain compliance Ethics Point matters (including monitoring and audit findings and self-reported cases)
・Review agreed Data Analytics tests and follow-up on red flags
・Provide local language support for roll-out of training & communications
・Act as local privacy officer or representative

応募条件

【必須事項】
・Compliance professional including strong assurance experience
・Demonstrated experience in multi-cultural arena
・Experience of working in global companies
【歓迎経験】
・医薬品または関連業界での実務経験
・法務に関連する学歴
・MBA
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】大阪

年収・給与

650万円～1000万円