Manager, Quality Assurance, Investigational Medicinal Products Pipeline Development, Shonan iPark / 湘南アイパーク 治験薬品質保証‐開発担当 課長代理

Role Summary

Manager, Quality Assurance, Investigational Medicinal Products Pipeline Development, located in Kanagawa (Fujisawa). Responsible for monitoring GMP compliance of development programs, providing QA input on development strategies, and approving manufacturing and testing methods for investigational medicines. Works with global teams to ensure GMP-aligned quality systems across countries and supports continuous quality improvement within the clinical drug development pipeline.

Responsibilities

• Monitor GMP compliance of development programs
• Provide QA perspective and recommendations on development policies
• Approve manufacturing and testing methods
• Release of investigational medicinal products (including review of manufacturing records)
• Change control for IMP manufacturing
• Investigate deviations, OOS/OOT, and complaints in IMP manufacturing
• Conduct GMP audits of suppliers and establish quality agreements
• Continual improvement of quality systems

Qualifications

• Required:
  Bachelor’s degree in pharmacy, chemistry, biology, engineering, or related sciences. Advanced degree (MS, PhD, PharmD) preferred.
• Experience: 8+ years in at least one of the following areas:
  • Quality assurance for development and manufacturing of IMPs (global development program experience preferred)
  • Manufacturing process development or analytical method development for IMPs
  • Manufacturing or testing of pharmaceuticals or IMPs
• Required knowledge: knowledge of development or testing method development for pharmaceuticals; knowledge of pharmaceutical manufacturing and testing; knowledge of current GMP requirements and guidance; ability to anticipate problems and proactively propose/execute solutions; ability to identify and resolve risks; ability to negotiate with stakeholders to reach mutually beneficial solutions
• Language: English with business proficiency in writing and speaking; Japanese required (business level) for daily work

Education

• Bachelor’s degree in a relevant scientific field required; advanced degree (MS, PhD, PharmD) preferred

Additional Requirements

• Hybrid work model; remote work possible when on-site presence is not required
• Domestic travel multiple times per year for GMP audits of contract manufacturing organizations