お仕事情報

お仕事情報

Manager Quality (Contract Lab and New Product):SS-4205MY

  • 外資系企業
  • 女性が活躍
  • 急募
  • 管理職・マネジャー
  • 英語を活かす

世界最大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

求人コード SS-4205MY
募集職種 Manager Quality (Contract Lab and New Product)
職務内容 ・Manages and be responsible for quality oversight of Contract lab including handling QC
testing schedule, OOS, invalid assay, sample and reagent arrangement, etc.
・Leads and manages new product launch readiness including quality deliverables (method transfer, qualification of LSP/Contract lab, etc.) and GMP inspection (paper and on-site).
・Leads and manages MRA plan and execution for applicable products and establish standard process for MRA application.
・Potential role for QMS manager of Medical Device and back-up QP (Hinseki).
・Manages and maintains our International & Distribution Quality (IDQ) GMP/GDP aligned with GQP and 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.
・Implements GxP system based on IDQ and GQP, such as Change control, Deviation, CAPA, Self-inspection, Training, Complaint, Recall, etc. This may also include Quality Management System contribution for ICH Q10 and other international standards.
・Implements IDQ projects, such as Operational Excellence, LCM, and other
commercialization activities, etc.
・Contributes partial change application including quality deliverables and GMP inspection (paper and on-site).
・Supports drug regulatory Inspections and medical device surveillance with us and our
colleagues.
・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.
・Supports shipment and distribution of Investigational Product and collaboration with our Clinical Manufacturing Site Quality to maintain product quality as needed.
応募要件 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 Quality oversight of contract lab.
・Experience of direct hands-in analytical method transfer.
・Pharmaceutical/ Biologics product commercialization and lifecycle management experience.
・Knowledge of regulatory authority inspection processes including paper based GMP
inspection.
・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
・Experience performing GMP audits that perform analytical testing of biologics, LSPs and packaging suppliers.

Preferred Qualification:
・Leadership experience leading teams, projects, programs or directing the allocation of
resources.
・Experience with Japanese and/or global 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
・Pharmacist license is desirable, but not mandatory.
勤務地 東京
年収 900万円~1300万円
最終学歴 大卒
推奨される資格要件 理系
その他

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