Manager, Quality Assurance, Investigational Medicinal Products Production, Shonan iPark / 湘南アイパーク 治験薬品質保証‐製造担当 課長代理

Role Summary

Manager, Quality Assurance for Investigational Medicinal Products Production at Shonan iPark, responsible for quality assurance activities related to GMP-compliant manufacturing of investigational drugs, including qualification/validation review, release, on-site monitoring, change control, investigations, supplier audits, internal and customer audits, and ongoing quality system improvements.

Responsibilities

• Review of qualification/validation documentation for sterile drug manufacturing equipment
• Release decisions (including review of manufacturing records)
• On-site monitoring of manufacturing activities and conducting internal audits
• Review of changes related to manufacturing
• Review of deviations, OOS/OOT, or complaints related to manufacturing
• Conduct GMP audits of raw material suppliers and establish quality agreements with suppliers
• Respond to internal and customer audits
• Promote continuous improvement of the quality system

Qualifications

• Required: Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related science field; advanced degree (MS, PhD, PharmD) preferred
• Required: 8+ years of experience in pharmaceutical or biotechnology industries
• Required: Experience taking responsibility in quality assurance, quality control, compliance, or manufacturing; cross-functional collaboration track record
• Preferred: Experience supporting global development programs and interactions with regulatory authorities
• Preferred: Quality audit qualifications or equivalent GxP audit experience

Skills

• Knowledge of sterile drug manufacturing processes and manufacturing equipment
• Knowledge of GMP requirements and guidelines for sterile drug manufacture
• Strong quality risk assessment and decision-making abilities
• Excellent communication and cross-functional collaboration skills
• High attention to detail and compliance mindset
• Ability to manage multiple priorities in a global environment
• Problem-solving abilities and drive for continuous improvement

Education

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

Additional Requirements

• Hybrid working model; on-site manufacturing work required during production activities, with remote work possible when not manufacturing
• Multiple domestic business trips per year for supplier GMP audits
• Location: Kanagawa, Fujisawa, Japan