QA Specialist CSV

Appealing Points:

• Lead Quality & Compliance in Global Pharma IT – Ensure GxP compliance, computer system validation, and data integrity across complex global IT systems and regulated processes.
• Drive Regulatory Excellence – Lead validation oversight, audit readiness, and quality governance while ensuring compliance with 21 CFR Part 11 and global pharmaceutical standards.
• Influence Enterprise-Wide Quality Initiatives – Partner with cross-functional global teams to improve validation processes, quality systems, and regulatory compliance through expert QA leadership.

Annual salary: 7 Million Yen and above

Job Responsibilities:

• GxP SLC Documentation Review & Compliance Oversight
  • Utilize risk-based approaches to validation oversight and quality decision-making across global IT and regulated business processes.
  • Provide QA oversight of change control activities associated with GxP electronic systems, ensuring changes are appropriately assessed, documented, approved, and validated.
  
  
• Regulatory Interpretation & Inspection Readiness
  • Interpret regulatory requirements related to electronic systems and data integrity (including Electronic Records / Electronic Signatures) to support and lead local and global process improvement initiatives.
  • Ensure inspection readiness for regulatory inspections, third-party inspections, and internal audits through effective validation oversight and quality system execution
  
  
• Policies, Procedures & SOP Governance
  • Develop, implement, and maintain policies, procedures, standards, and tools in support of validation processes, data integrity, and quality systems.
  • Monitor SOP development and lifecycle management to ensure alignment with regulatory expectations and company (pharma) standards.
  
  
• CrossFunctional QA Leadership & Engagement
  • Provide expert guidance and consultation to regulated functional areas on validation, ERES, data integrity, and quality systems matters.
  • Manage QA oversight of IT processes, electronic systems, and validation projects to assure quality, compliance, and consistency across the organization.
  
  
• Continuous Improvement & QA Representation
  • Participate in continuous improvement programs and represent QA management on cross-functional initiatives, providing regulatory and technical expertise to drive innovation and process efficiency across validation and quality systems.
  
  
• Documentation Management
  • Author, revise, and maintain controlled documentation such as SOPs, Work Practice Documents (WPDs), Standards, Templates, and Logs (STLs), as required to support departmental and organizational quality objectives.
  
  

Job Qualification:

• Science-based degree.
• Demonstrated experience of computer system validation activities for complex, global IT projects.
• Knowledge and practical expertise typically acquired through an extensive career in progressively larger and more complex roles.
• Experience coaching and leading remote teams across cultures and geographic regions; proactive in knowledge sharing and best practices.
• Thorough knowledge of GxP regulations (including 21 CFR Part 11) and computerized systems within a pharmaceutical GxP-regulated environment, combined with broad quality systems knowledge and awareness of industry trends.
• Experience leading GxP IT system and process audits with successful inspection outcomes.
• Working knowledge of computer system validation lifecycle requirements and change control programs.
• Ability to establish and maintain effective relationships with internal and external stakeholders, including Global entities.
• Self-starter with strong organizational skills and the ability to manage workload independently; demonstrates pragmatic, risk-based quality decision-making.
• Excellent written and verbal communication, interpersonal, facilitation, and influencing skills, with the ability to work effectively across the organization and external partners.

Language Skills: Business level Japanese (JLPT N2) and Business level English

Company Description:

One of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era.

Their unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses.

Headquartered in the U.S., this company is one of the Fortune 500 companies and is consistently listed among the most admired companies in the world.

[Passive smoking measures]

Indoor smoking

Designated smoking area

. Skillset Required: GxP compliance, computer system validation, data integrity, audit readiness, quality governance, compliance with 21 CFR Part 11, pharmaceutical standards, policies and procedures development, SOP governance, QA leadership, regulatory compliance, documentation management, coaching and leading remote teams, knowledge sharing, GxP regulations, computerized systems in pharmaceutical environment, GxP IT system audits