Senior Manager, Product Quality Assurance, Japan

The Opportunity:

The Senior Manager, Product Quality Assurance serves as a Product Quality Representative within the Japan Quality Assurance organization and is responsible for executing and coordinating day-to-day Product Quality Assurance operations that support the Japan Marketing Authorization Holder (MAH) organization.

For assigned products, this role drives Quality Assurance activities throughout the product lifecycle and leads product quality activities including product release support, quality information management, product complaint handling, recall management, GDP-related quality activities, regulatory inspection support, and product launch readiness activities.

Working closely with internal and external stakeholders, the position promotes the effective operation of quality processes, quality event investigations, quality risk assessments, and continuous improvement initiatives, while contributing to the development and growth of the Japan Quality Assurance organization.

Key responsibilities:

Quality System and Process Development

Participate in the establishment, implementation, operation, and continuous improvement of Quality Systems and Quality Processes within the Quality Assurance organization.

• Drive the effective execution of quality processes within assigned areas of responsibility.

• Maintain an effective cross-training and backup structure within the QA organization, as appropriate.

Product Launch Readiness

• Lead Product Quality Assurance activities supporting product launch readiness in Japan.

• Support the implementation and sustainable operation of Japan-specific regulatory requirements within the Global Quality System throughout the product lifecycle.

External Partner Management

• Support quality audits of external partners.

• Support the establishment, maintenance, and periodic review of Quality Technical Agreements (QTAs) with Contract Manufacturing Organizations (CMOs), logistics providers, warehouses, call centers and other GxP service providers.

• Conduct routine quality reviews and quality oversight activities for outsourced operations.

Market Release and Product Quality Assurance

• Review and/or approve quality records as delegated and in accordance with established procedures supporting product release activities.

• Support final quality decisions regarding significant quality events and product disposition decisions.

• Ensure that quality assessments are completed appropriately to support product release decisions.

Quality Event Management

• Lead product Deviations, CAPAs, Change Controls, Quality Information, Product Quality Complaints and other quality events related to assigned products.

• Conduct investigations, root cause analyses, and quality risk assessments.

• Ensure timely escalation and follow-up of significant quality issues.

Quality Metrics

• Collect data and prepare inputs for Annual Product Reviews (APRs) and Management Reviews.

• Conduct trend analyses and identify potential quality risks and improvement opportunities.

• Drive continuous improvement initiatives based on quality metrics and quality performance trends.

Regulatory Inspection Support

• Lead inspection readiness activities within assigned areas of responsibility.

• Support and participate in regulatory inspections and audits.

• Prepare and maintain documentation required for inspection and audit activities

Required Skills, Experience and Education:

• Bachelor's degree or higher in Pharmacy, Chemistry, Biology, Engineering, Science, Biotechnology, or a related scientific discipline.

• Minimum 3 years of Quality Assurance experience within the pharmaceutical industry.

• Knowledge of and experience with GQP, GMP, GDP, and applicable pharmaceutical regulations.

• Experience supporting regulatory inspections and audits.

• Experience working with GxP service providers, such as Contract Manufacturing Organizations (CMOs), logistics providers, warehouses and call centers.

• Practical experience with product release, Deviation management, CAPA, Change Control, Quality Information and Product Quality Complaints management.

• Strong problem-solving and cross-functional collaboration skills.

• Ability to work effectively in global and cross-functional environments.

• Business-level English and native-level Japanese language proficiency.

Preferred Skills:

• Experience serving as a Product Quality Lead or Product Quality Representative for assigned products within a Japan MAH organization.

• Experience supporting product launch readiness and post-marketing Quality Assurance activities within a Japan MAH organization.

• Experience establishing or improving Quality Systems.

• Experience establishing, managing, and maintaining Quality Technical Agreements (QTAs) and outsourced quality activities.

• Experience collaborating with Pharmacovigilance, Regulatory Affairs, and Supply Chain functions.

• Experience supporting regulatory inspections and audits.

• Experience as a GxP auditor

• Experience in CMC-related functions, including API process development, formulation development, analytical method development, or CMC regulatory affairs.

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