仕事内容The Global QA&RA Compliance Principal Auditor will be responsible for the support of the Global QMS Internal Audit Process and execution of global internal audits. Will lead Quality System audits throughout the organization to assess compliance of the quality system to applicable regulations, standards, and internal requirements. Serves as auditing subject matter expert and provide guidance on the interpretation of applicable regulations and standards. Will collaborate with stakeholders and partners to support the development and execution of a global internal audit program and supporting tools / resources that enhance internal audit capabilities.
・Lead quality system audits throughout the global organization and all company locations that provide assurance of the compliance and effectiveness of the quality system.
・Supports the establishment of a global internal audit program and execution of internal audit schedules.
・Support the development and delivery of internal audit training activities throughout the organization.
・Coordinate and support requests for directed audits, received from senior management and other customer/business partners.
・Serves as an Expert on applicable regulatory requirements, their interpretation, and application.
・Support external inspections and audit management for various sites, which will include site inspection/audit readiness and execution, as needed.
・Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed.
経験・資格●Education:
Bachelor's degree
(Preferred; Engineering discipline or equivalent)
●Experience:
・Related professional experience in medical device or pharma industry.
・Experience of auditing quality systems in a medical device or pharma environment is required.
・Requires background and familiarity with applicable regulatory requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA.
・Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
・Experience writing, reviewing, and providing feedback on audit responses, is highly valued.
・Experience working in a global organization and collaborating with multiple regions / company locations.
●Skills:
・Interpersonal skills to develop and manage good working relationships with all this company locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc…).
・Proven leadership, teamwork, collaboration and influencing skills.
・Ability to work effectively in a fast paced and dynamic environment.
・Working knowledge of problem-solving skills good statistical and analytical skills.
・Strong written and verbal communication skills.
・Proficient in the use of Information Technology.
・Fluent in Japanese and / or English language (desired but not required)
●Other Considerations (travel/hours availability, etc.):
・Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. Domestic and international travel up to 50 % of the time should be expected.
勤務地
年収
Recruiting No.
社名
事業内容
ひとことコメント
【東証プライム上場 財閥系 海運会社】 本社 陸上総合職
東証プライム上場 エネルギー会社グループ 風力発電事業会社
東証プライム上場 産業ガスメーカー 品質管理課 空気分離装置の品質管理
人の営みと地球環境が調和できる社会。 車載電池は一つの有効な手段になる。
多くの人が待ち望み、誰も作れなかった新薬を高度な技術で生産し、世界市場に届けます。
創業120年超、蓄積された技術資産を活用し、 多様な領域でトップクラスのシェアを確立。 グローバル事業の拡大も加速させています。
「夢に見るほど電池が好き」 な社員たちが、化学・電気・機械のノウハウを結集し、次世代エネルギーデバイスの開発に挑む。
エネルギー、インフラ、ストレージ。3つの注力事業において、新しい人材が 「新生東芝」 を動かし始めています。
成長への 「挑戦の第二幕」 に向けて、地に足を着けたチャレンジャーが活躍中。
