Specialist QA(Manager)
5 日前


  • Creates QMS and GQP operating procedures per the Pharmaceutical and Medical Devise Affairs Law (PMDAL) - products may include sterile injectable monoclonal antibodies and proteins in vials, syringes and devices (combination products);
  • and small molecules in solid oral dosage form. Contributes to our mission, vision and strategy. Leading projects such as new product launch, operational excellence, etc.

    Contributes to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities.

    Manage GxP system (CAPA, Change Control, Deviation, Self-inspection, Training,Complaint, Recall, etc.) Supports drug regulatory Inspections and medical device surveillance with ourcolleagues.

    Quality oversight of Contract Manufactures, Contract Laboratories and Logistic Service Providers (LSPs) as needed. Supports shipment and distribution of Investigational Product and collaboration with usClinical Manufacturing Site Quality to maintain product quality as needed.

    Contributes implementation of Quality Management System and Standard Procedures per ICH Q10 and PMDAL; to include Information Systems and GMP Procedures.

    Supports Audit program management for key Japanese suppliers to us. These suppliers may include Contract Laboratories, final packaging materials suppliers and LSPs.

    Contributes the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements.

    Potentially role for back-up QP (Hinshitsu Hosho Sekininnsya) and Medical Device product complaints improvement SME.


    世界最大級の独立バイオテクノロジー企業と 内資系研究開発型グローバル製薬企業との合弁会社高脂血症治療薬 骨粗鬆症治療薬 抗がん剤領域等合計6つの開発品目について日本における開発及び商業化を行っております

    必要な経験 能力

    Basic Qualification Doctorate 2, Masters 4, Bachelors 5 years of directly related experience in quality assurance and quality related activities.

    Demonstrated ability to manage relationship development and maintenance and negotiation skills. Experience performing GMP audits that perform analytical testing of biologics, LSPs and packaging suppliers.

    Experience working with Medical Device in Quality or CMC. Pharmaceutical / Biologics product commercialization and lifecycle management experience.

    Knowledge of regulatory authority inspection processes Experience in Japan with multiple language capability (English, Japanese) Strong verbal and written communications skills.

    Must be able to effectively articulate ideas with same levels of an organization. Self leadership and motivation with high personal integrity and application of our Values in daily operations.

    Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a team of seconded staff.

    Ability for travel to international destinations as needed Preferred Qualification Leadership experience leading teams, projects, programs or directing the allocation of resources.

    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 Investigational Medicinal Products (IMP) and commercial products Experience with medical devices in Japan

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