Quality Assurance Manager Associate

The Quality Assurance Manager / Associate position is responsible for all quality operations within the IPSEN Japan affiliate. She/he assists in deploying and maintaining the Quality Management System (QMS) with Quality Assurance Manager (HinSeki).

The incumbent is responsible for establishing and maintaining relationships with manufacturing and distribution channels, collaborates with Global Quality and Technical Operations to ensure the commercial affiliate of IPSEN operates according to global and local GQP, GMP and GDP standards.

She/he needs to show technical expertise in quality arena, leadership to drive special projects across Japan and with global cross functional teams.

Main Responsibilities

• Act as the local quality assurance/quality system representative for IPSEN Japane.
• Establish and maintain Affiliate Quality Management System (QMS) and Quality Assurance activities to ensure compliance with all regulatory and GxP requirements.
• Conduct local supplier assessment and oversight including QTAs maintenance and local audits conduct.
• Control and supervise the reception, repacking, testing, product release, warehousing and distribution of the IPSEN products by the local third parties from the quality viewpoint.
• Ensure management of the distribution activity, being responsible for local Authorities and maintain contact for distribution issues from the quality viewpoint.
• Drive remediation plan when a product quality or GxP process issue is identified.
• Set up comprehensive training program and perform training for relevant GxP members regarding Affiliate QMS implementation.
• Implement and manage Change Control systems/activities and Product Complaints systems/activities.
• Assure Deviation management including temperature excursion and CAPA management.
• Assist Crises Management Teams as local Product Recall Lead in the case of Product Recall.
• Ensure the Affiliate self-inspection, audit readiness and business continuity systems and activities are in place and implemented to cover GxP processes.
• Conduct mock-recalls and Act as the Affiliate Product Recall Lead when the situation arises.
• Coordinate and prepare for the local supplier audits and regulatory inspections.
• Ensure Quality Management Review and KPIs are established.
• Assist distributors complying with the guidelines of Good Distribution Practices (in particular cold chain and transportation).
• Support, oversee and manage any local analytical product release activities (Analytical transfers; Protocol and Report reviews; facilitate troubleshooting; support any OOS; Product release, if applicable).
• Develop relationship and closely work with Global Quality, Affiliate Quality Managers and Partner Quality managers.
• Act as Quality interface for local distribution partners.
  
  

• Bachelor’s Degree in Pharmaceutical Sciences (or another scientific discipline)
  
  

• Master’s Degree in Pharmaceutical Sciences (or another scientific discipline)
  
  

• Proven experience in Quality Assurance and/or Quality Management Systems
• Thorough knowledge of local regulatory requirements
• Experience in writing and implementing SOPs is essential
  
  

• Experience in working at both MAH HQs and GMP manufacturers
  
  

• Fluent Japanese
• English (business level)