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[Innovative Medicine] Quality Head
年収：1300万 ～ 1900万
採用企業案件
ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | [Innovative Medicine] Quality Head |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
■Position Summary: Responsible for the Site Quality Department, including all product quality, quality compliance and controlled substance related activities at site. Is accountable for adequate monitoring of the quality systems to ensure that it is adequately managed, and products manufactured at site is properly inspected, tested, packaged and released to the Japanese Market. Quality metrics is managed through the Tier system and BPM. Must also support the Qualified Person and other legal positions in the department. Also supports the introduction of the NPI into the Japanese market. In addition, also responsible for guiding, mentoring, coaching, training, and developing both the quality units and other departments personnel at site. Communicates department objectives aligning with regional, site and Japan BU objective. Participate in planning and implementing overall global and site strategy. Also responsible for championing Credo, Quality Culture, and reliability improvement activities at the site. ■Regulatory Compliance Responsibilities: The Quality Department must be compliant with the following laws and regulations (but not limited to) • Pharmaceutical and Medical Device Act • Japanese GMP • Narcotics and Psychotropics Control Law • GCTP Ordinance • Official compendium such as JP, USP and EP etc. • EHS standards and related regulations such as Poisonous and Deleterious Substances Control Law etc. • Corporate standard and JSC SOPs. ■Major Job Duties and Responsibilities: • Responsible monitoring the effectiveness of the sites quality system and compliance through forums such as the following but not limited: • Management Review • Quality Council • DI Council • Site quality risk register • Tiers and BPM • Monthly and quarterly reports such as APR, complaints • Validation steering committee • Participate and support Site initiatives which are identified through requirements of the site SLT and Board Meetings • Champions site initiatives such as DI, Credo and Quality Day, and quality culture |
| 応募資格 |
【必須（MUST）】 Education and Experiences:• Bachelor's degree or equivalent education in science, chemistry, biology, biotechnology, microbiology, or related fields • A minimum of 15 years’ experience within the biological, pharmaceutical and or medical device industry. • Knowledgeable of PMDA/MHLW/GCTP/JP regulatory requirements applicable to biologics and/or pharmaceuticals. • Advanced degree (MS, MBA, PhD) preferred. Knowledge, Qualification and Skills: • GMP, Narcotics, Psychotropics, QMS and Data Integrity • Pharmaceutical regulations, standards, and guidelines • Effective communication in Japanese and English • Proficiency with Microsoft Office software programs are required. Core Competencies: • Credo value of integrity • Comply with EHS rules and procedures at all times • Report all incidents, accidents, and near miss events • Collaboration and teamwork • Excellent interpersonal skills • Ability to operate as part of a team is critical • Customer focus • Excellent communication skills both written and verbal • Good problem-solving and coaching skills. |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/08/14 |
| 求人番号 | 5006708 |
採用企業情報
- ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
さんの手元に届けることができるよう取り組んでいます。
私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
（Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
ライフ）の向上を目指した支援活動などをおこなっています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です