PQQIアソシエイトディレクター/ PQQI Associate Director

An international pharmaceutical company is seeking an Associate Director, Product Quality & Quality Information (PQQI). The selected candidate will lead product quality and quality information functions, ensuring compliance, operational excellence, and cross-functional alignment across the full product lifecycle. This is a hybrid setup role.

Responsibilities:

• Define and execute the strategic direction of the Product Quality & Quality Information function aligned with Japan QA strategy
• Lead and manage the PQQI team including Product Quality and Quality Information leaders while ensuring effective GQP operations
• Drive organisational integration across PQ and QI functions to improve quality outcomes and operational efficiency
• Oversee performance management, talent development, resource allocation, and capability building within the team
• Ensure GQP, QMS, GMP, and GDP compliance across product lifecycle activities including product release and complaint management
• Maintain inspection readiness and support PAI and GMP inspections across manufacturing, packaging, and supply sites
• Establish and maintain SOPs and quality systems in compliance with applicable pharmaceutical regulations and corporate standards
• Manage product release processes and review changes and deviations in line with GQP requirements
• Drive process simplification and continuous improvement across quality information and complaint handling systems
• Monitor quality metrics and ensure timely, accurate quality reporting to internal and external stakeholders
• Collaborate with global and local teams including QA, regulatory, manufacturing, and call centre functions
• Ensure readiness for new product launches and provide quality input during development and pre-launch phases

Requirements:

• Bachelor’s degree or above in pharmacy, chemistry, biology, engineering, or related health science field
• More than 5 years of experience in GQP, QMS, GMP, or GDP quality operations within the pharmaceutical industry
• Experience in a leadership role within regulated pharmaceutical quality environments
• Strong knowledge of GQP, QMS, GMP, GDP, and related corporate quality standards
• Strong cross-functional leadership and stakeholder management experience in global organisations
• Proficient in English and Japanese

Preferred requirements:

• Advanced degree in pharmacy, chemistry, biology, engineering, or related field
• Experience in marketing affiliate quality operations and sourcing site management

About the Company:

A global pharmaceutical organisation focused on innovative medicines and healthcare solutions across major therapeutic areas. The company operates internationally with a strong commitment to scientific advancement, quality, and patient outcomes.

Keywords:

品質保証, 製品品質, 品質管理, 医薬品, 規制対応, 求人, 外資系

Job Ref: OZJB65