Job description
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.