Associate Director QA - Hinseki

Lead quality and compliance activities for the Japan organization, ensuring alignment with global standards, GxP/GDP/PV requirements, and local regulations. Support technical transfers, validation, manufacturing oversight, and product release activities with local and global manufacturing partners. Represent Quality in CMC and commercial projects, driving inspection readiness, risk management, CAPAs, and continuous process improvement.

Review and approve GMP quality documents, including investigations, change controls, validations, specifications, complaints, and batch records. Provide leadership, cross-functional collaboration, vendor management, budget oversight, and team development support.

Responsibilities

Ensure products are manufactured, tested, released, and distributed in compliance with SOPs, cGMP/GMP, GQP, GDP, and applicable regulatory requirements. Lead quality decision-making, including product release, rejection, recalls, returned goods disposition, and approval of saleable stock. Review and approve GMP quality documents, quality agreements, subcontracted activities, suppliers, customers, and other quality-related processes.

Maintain and strengthen quality systems through training, self-inspections, record management, complaint handling, CAPAs, and continuous compliance oversight. Support implementation and ongoing maintenance of quality management systems and regulatory compliance programs.

Requirements

8+ years of Quality Assurance, Compliance, and leadership experience in the pharmaceutical or biotech industry. Strong knowledge of GxP regulations, quality systems, CMC processes, process validation, QC testing, and global regulatory requirements (e.g., FDA, EMA, PMDA). Proven ability to manage cross-functional and global matrix environments while adapting to evolving business and compliance needs.

Excellent leadership, organizational, communication, and stakeholder management skills, including collaboration with external partners and laboratories. Fluent in English and Japanese.