Senior Manager QA

• Maintain and improve the Japan Quality Management System covering GMP/GDP requirements

• Develop, maintain, and implement quality-related SOPs, procedures, and documentation

• Support local MAH quality responsibilities and ensure appropriate product release

• Establish and maintain Quality Technical Agreements and quality agreements with external partners

• Provide QA oversight of CMOs, contract warehouses, and other external service providers

• Support GMP/GDP inspections and communicate relevant regulatory inspection requirements internally

• Plan and conduct internal self-inspections and support inspection readiness

• Manage training, documentation, and record control activities

• Oversee Change Control and Annual Product Quality Reviews

• Manage product complaints, recalls, and quality-related issues in collaboration with relevant functions

• Support management of suspected falsified product cases

• Maintain approved product dossiers in collaboration with Regulatory CMC

• Act as a key liaison between global Quality teams and external suppliers

• Provide QA input to cross-functional projects involving R&D, Manufacturing, Supply Chain, Distribution, Quality, and Regulatory teams

The Senior Manager, Quality Assurance will be responsible for maintaining and strengthening the Japan Quality Management System and supporting local quality and compliance responsibilities.

The position will serve as a key Quality contact for internal stakeholders, global teams, external suppliers, contract manufacturers, warehouses, and other service providers. The role also has responsibility for supporting product release activities and acting as a local delegate for qualified-person-related responsibilities, where applicable.

Requirements

• Extensive pharmaceutical industry experience, ideally 15+ years in Quality Assurance, Quality/Compliance, Regulatory, or a related field

• Strong knowledge of GMP/GDP and applicable Japanese pharmaceutical regulations

• Experience working with Japanese regulatory authorities and supporting inspections

• Experience with CMO/vendor oversight and quality agreements

• Experience with Quality Management Systems, self-inspections, Change Control, APQR, complaints, and recalls

• Knowledge of Japanese, EU GMP, and ICH guidelines

• Understanding of GQP and pharmaceutical quality-related regulations

• Experience with Supply Chain-related quality activities, including distribution and cold-chain products

• Knowledge of pharmaceutical CMC and/or biologics is advantageous

• Previous people management or team leadership experience

• Strong Japanese and English communication skills

Benefits

• Senior Quality Leadership: Take a key role in the Japan Quality organization with broad responsibility across QA and compliance.

• Cross-functional Exposure: Work closely with Global Quality, Regulatory, Supply Chain, Manufacturing, R&D, and external partners.

• Strategic Scope: Opportunity to influence and continuously improve the Japan Quality Management System rather than focusing solely on operational QA activities.

• External Stakeholder Exposure: Act as an important Quality interface with suppliers, CMOs, warehouses, and regulatory stakeholders.

• High Visibility: Work in a global organization where the Japan Quality function plays an important role in ensuring product quality and regulatory compliance.

• Broad Product Lifecycle Experience: Gain exposure to quality activities spanning manufacturing, supply, distribution, product release, post-marketing quality, and regulatory requirements.