職務概要 Position Summary: 

• The Senior Manager of Quality provides quality and compliance leadership for manufacturing activities at the Fuji Site. The role is responsible for ensuring GMP compliance, product quality, inspection readiness, quality system effectiveness, and operational excellence across manufacturing operations. 

• The position provides strategic quality oversight for commercial and Advanced Therapy products manufactured at the site and partners closely with sourcing sites for shared products and supply continuity. The role also collaborates extensively with Commercial Quality (GQP) and other cross-functional stakeholders to ensure robust quality decision-making, effective risk management, and uninterrupted product supply to patients. 

法規制の順守に関する責任  Regulatory Compliance Responsibilities: 

The Quality Senior Manager complies with all applicable regulations, including the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, GMP/GCTP requirements, Narcotics and Psychotropics Control Law, corporate standards, policies, and procedures. 

The role ensures that all quality activities are performed in accordance with regulatory requirements and company expectations while maintaining patient safety, product quality, and data integrity. 

主な職務及び責務  Major Job Duties and Responsibilities: 

Quality Oversight 

• Provide quality leadership and oversight for manufacturing operations at the Fuji Site. 

• Support commercial and Advanced Therapy product manufacturing activities from a quality and compliance perspective. 

• Ensure manufacturing activities are conducted in compliance with GMP requirements and company standards. 

• Promote a strong quality culture and continuous improvement mindset across the site. 

• Support site readiness for regulatory inspections, audits, and compliance assessments. 

Quality Systems & Investigations 

• Review and approve deviations, investigations, CAPAs, change controls, Validation documents and quality risk assessments. 

• Ensure investigations are scientifically sound, timely, and supported by robust root cause analysis. 

• Lead and support the resolution of complex quality issues and compliance challenges. 

• Drive effective implementation and verification of corrective and preventive actions. 

• Ensure lessons learned are communicated and leveraged to prevent recurrence. 

Quality Performance & Continuous Improvement 

• Monitor and drive Quality KPI performance to ensure sustainable compliance and operational excellence. 

• Analyze quality trends and identify opportunities for improvement. 

• Lead initiatives to improve quality system effectiveness, product quality, compliance performance, and operational efficiency. 

• Facilitate Kaizen and continuous improvement activities within Quality Operations and across the site. 

Sourcing Site Collaboration 

• Collaborate with sourcing sites for shared products to address quality, compliance, supply, and continuous improvement opportunities. 

• Support investigation activities, issue resolution, and risk assessments impacting shared products. 

• Participate in regular quality governance and performance discussions with sourcing site partners. 

• Promote effective knowledge sharing and alignment of quality expectations across sites. 

Commercial Quality (GQP) Partnership 

• Maintain strong collaboration with Commercial Quality (GQP) to support product disposition, complaint management, Annual Product Quality Reviews, market actions, and post-marketing quality activities. 

• Partner with Commercial Quality to assess quality risks and ensure timely escalation and resolution of quality issues. 

• Support the achievement of business objectives while maintaining compliance and patient focus. 

 People Leadership 

• Lead, coach, develop, and engage a high-performing Quality Operations organization. 

• Foster accountability, collaboration, and continuous learning within the team. 

• Build organizational capability and support talent development and succession planning. 

• Ensure appropriate prioritization of activities to balance compliance, business, and patient needs. 

EHS 

• Ensure compliance with site EHS requirements and procedures. 

• Promote safe working practices and promptly escalate EHS concerns. 

• Support a culture that prioritizes employee safety, product quality, and environmental stewardship. 

Data Integrity, Computer & Automation Systems 

• Ensure the appropriate use of computerized systems supporting quality and manufacturing operations. 

• Maintain compliance with data integrity requirements and information security policies. 

教育/経験 Education and Experiences: 

• Bachelor's Degree in Pharmacy, Life Sciences, Biotechnology, Engineering, or a related scientific discipline.  

• Minimum 10 years of experience in the pharmaceutical, biotechnology, or other GMP-regulated industry.  

• Demonstrated experience in Quality Operations, Quality Systems, Manufacturing Quality, or Quality Compliance.  

• Experience supporting manufacturing operations within a regulated environment.  

• Experience managing large teams and developing people leaders.  

• Experience interacting with regulatory agencies and supporting inspections is preferred. 

知識、資格、及び技能 Knowledge, Qualification and Skills:  

• Strong knowledge of GMP regulations and pharmaceutical quality systems.  

• Strong understanding of deviation management, investigations, CAPA, change control, and quality risk management.  

• Demonstrated expertise in root cause analysis and problem-solving methodologies.  

• Proven ability to assess complex situations, exercise sound judgment, and make risk-based decisions.  

• Strong Quality KPI management and performance monitoring capabilities.  

• Excellent stakeholder management and influencing skills across all organizational levels.  

• Strong collaboration skills with Manufacturing, Supply Chain, Technical Operations, Regulatory Affairs, Commercial Quality (GQP), and Global Quality organizations.  

• Ability to lead through ambiguity and manage complex quality and business challenges.  

• Strong leadership, coaching, communication, and presentation skills.  

• Knowledge of Lean, Continuous Improvement, and Kaizen methodologies. 

行動特性Core Competencies:  

• Integrity and Credo-Based Leadership 

• Leadership  

• Strategic Thinking  

• Quality Risk Management  

• Critical Decision Making  

• Stakeholder Influence  

• Collaboration and Teamwork  

• Customer and Patient Focus  

• Accountability  

• Continuous Improvement  

• Compliance Mindset  

• People Development  

• End-to-End Business Understanding