QA Operations Manager

Key Responsibilities

• Oversee routine quality operations at CMOs involved in cell therapy manufacturing.
  
• Ensure manufacturing activities comply with regulatory requirements, approved submissions, and quality agreements.
  
• Review batch records to support product disposition decisions.
  
• Review and/or approve deviations, investigations, CAPAs, and controlled documents (e.g., master batch records).
  
• Assess and approve quality impact of changes related to CMOs.
  
• Review and/or approve chain-of-identity (COI) risk assessments and process maps.
  
• Conduct and support quality risk assessments.
  
• Support data audits and review protocols/reports for regulatory submissions.
  
• Review and approve annual product quality reports from CMOs.
  
• Collaborate with global quality teams to ensure timely implementation of audit-related corrective actions.
  
• Partner cross-functionally to define and implement process improvement initiatives, representing quality throughout execution.
  
• Lead and support quality improvement projects with CMO partners.
  
• Establish and monitor CMO-related KPIs and performance metrics.
  
• Provide quality oversight for distribution activities, including product disposition and distribution.
  
• Support the responsible quality lead in final product release activities in Japan.
  

Requirements

Required Qualifications

• Strong organizational skills with the ability to manage tasks through to completion.
  
• Proven ability to lead, influence, and negotiate effectively with external partners.
  
• In-depth knowledge of relevant regulations and guidance; able to serve as a subject matter resource.
  
• Strong independent decision-making skills with the ability to assess broader impact.
  
• Adaptability to changing priorities and business needs.
  
• Advanced written and verbal communication skills in both Japanese and English.
  
• Ability to collaborate effectively within cross-functional teams.
  

Preferred Qualifications

• Experience in cell therapy or related advanced therapeutic environments.
  
• Experience supporting both commercial and clinical products.
  
• Strong project management skills, including process improvement methodologies (e.g., process mapping, root cause analysis).
  
• Ability to prioritize and manage multiple complex projects simultaneously.
  
• Detail-oriented with strong problem-solving and decision-making skills.
  
• Ability to thrive in a fast-paced environment.