募集要項
- 仕事内容
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Key Responsibilities:
* Serve as the primary quality point of contact for products at external sites.
Manage external sites to meet contractual obligations related to quality agreements, specifications, safety, and regulatory requirements.
* Review and/or approve completed production batch records, deviations, master batch records, change controls, and audit/inspection responses as necessary.
* Interpret and apply applicable GMP regulations for manufacturing and testing activities at external sites.
* Oversee the manufacturing, testing, and release of products at external sites.
* Develop and implement actionable site inspection readiness plans.
* Identify and mitigate risks at external sites.
* Monitor and communicate site performance through quality metrics and periodic reviews.
* Escalate risks or roadblocks to management.
* Drive continuous improvements and align with company-first mindset.
* Perform batch disposition activities to support lot release.
- 応募資格
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- 必須
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* Bachelor’s degree with 5 years of directly related experience.
*Proven ability to manage relationship development, maintenance, and negotiation skills.
*Experience performing GMP audits of laboratories for analytical testing of biologics, LSPs, and packaging suppliers.
*Experience in pharmaceutical/biologics product commercialization and lifecycle management.
*Knowledge of regulatory authority inspection processes.
*Experience in Japan with proficiency in English and Japanese.
*Strong verbal and written communication skills; ability to effectively articulate ideas at all organizational levels.
*Demonstrated interpersonal skills, including temperament and objectivity for effective team interactions.
*Leadership experience in leading teams, projects, programs, or resource allocation.
- 歓迎
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*Doctorate degree with 2 years of directly related experience, or
Master’s degree with 4 years of directly related experience
*Experience with Japanese pharmaceutical companies.
*Experience working with biologics (monoclonal antibodies and/or proteins) and small molecule solid oral dosage forms in Japan.
*Experience with commercial products.
*Experience with medical devices in Japan.
- 募集年齢(年齢制限理由)
- 長期勤続によりキャリア形成を図るため (長期勤続によりキャリア形成を図るため)
- フィットする人物像
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こんな方なら向いている
ー 強い製品パイプラインを持ち、日本オフィスの変革期においてバイオ系製品の品質保証業務を幅広く携わりたい方
ー 意思決定の進み方がスピーディーでしやすく、革新的な技術をもっている企業で働きたい方
ー 柔軟的な働き方をしながら業務に携わりたい方(ハイブリッド勤務+スーパーフレックスタイム制)
- 雇用形態
- 正社員
- 勤務地
- 埼玉県 / 千葉県 / 東京都 / 神奈川県
- 年収・給与
- 1100万円 ~ 1300万円程度で想定されています
- 休日休暇
- 土日祝
- 選考プロセス
- 書類選考、面接2-3回
- キャリアパス・評価制度
- 将来は社内においてマネージャー、シニアマネージャーへの昇進が視野にはいっている