Japanese Quality Assurance Engineer Jobs in Rochester, NY

Senior Consultant - Digital Quality & Compliance

Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect, and transform their organization. Join our team and use advanced data, AI, and emerging technologies with industry insights to help clients bring clarity from complexity and accelerate their path to value creation.

Work you'll do

As a Senior Consultant, Strategy, Growth, and Transformation on the Regulatory, Risk & Forensic team, you will be responsible for leading validation and compliance activities for complex GxP systems across regulated technology environments.

• Lead end-to-end validation activities for GxP systems, including validation plans, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) protocols, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
• Lead computer system validation (CSV) and computerized system assurance (CSA) deliverables across the shop-floor systems lifecycle (L2 to L6), including risk assessments, validation planning, requirements traceability, test strategy and execution, deviation management, final reporting, and release approval
• Apply risk-based validation principles to assess system impact, classify validation requirements, and support compliance with GAMP 5, 21 CFR Part 11, European Union Annex 11, and data integrity requirements
• Drive inspection readiness activities, including gap assessments, mock audits, validation package reviews, and support for regulatory inspections and responses
• Lead corrective and preventive action (CAPA) activities and support validation approaches for artificial intelligence and machine learning-enabled GxP systems and automation testing frameworks, including documentation of governance requirements for non-deterministic outputs

A successful candidate would possess these skills:

• Ability to work independently and collaborate as part of a team
• Effective written and verbal communication skills
• Meticulous attention to detail and quality of work product
• Ability to build and sustain professional relationships
• Ability to lead projects or workstreams
• Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment
• Strong interpersonal skills and professional demeanor
• Ability to meet deadlines
• Ability to provide clear guidance to others

The team

Our Enterprise Operations & Risk offering enables clients to achieve profitable growth and competitive advantage by optimizing "heart of the business" operations. We leverage deep domain expertise to extend enterprise resilience, agility and remediation. Our professionals address client needs which span the organization and impact strategy, operations, performance and reputation.

Qualifications

Required:

• Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience and 6+ years of experience in computer system validation in a life sciences environment, including pharmaceutical, biotechnology, medical device, or clinical environments
• Experience leading validation deliverables for GxP systems and computer system validation (CSV) and computerized system assurance (CSA) activities across the shop-floor systems lifecycle (L2 to L6), including validation plans, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) protocols, summary reports, user requirements specifications, functional specifications, design specifications, traceability matrices, risk assessments, test strategy and execution, deviation management, final reporting, and release approval
• Hands-on understanding of PLC/SCADA architectures, control strategies, alarms
• Experience applying 21 CFR Part 11, European Union Annex 11, GAMP 5, and data integrity requirements, including Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA+) principles
• Experience managing CAPA lifecycle activities, supporting inspection readiness for Food and Drug Administration (FDA) or European Medicines Agency (EMA) audits, and validating artificial intelligence/machine learning (AI/ML)-enabled systems or automation testing frameworks
• Ability to travel 10%, on average, based on the work you do and the clients and industries/sectors you serve.
• Limited immigration sponsorship may be available.

Preferred:

• Experience supporting periodic review programs for validated systems and associated CAPA triggers
• Experience validating cloud or software as a service platforms, including Veeva, ServiceNow, or Salesforce, in a GxP environment
• Experience working in Agile delivery environments with validation activities embedded in sprints
• Experience with AI governance processes, including AI use case tracking, model risk classification, and disclosure requirements for GxP systems

The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $110,700 to $218,300.

You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.

Senior Consultant - Digital Quality & Compliance

Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect, and transform their organization. Join our team and use advanced data, AI, and emerging technologies with industry insights to help clients bring clarity from complexity and accelerate their path to value creation.

Work you'll do

As a Senior Consultant, Strategy, Growth, and Transformation on the Regulatory, Risk & Forensic team, you will be responsible for leading validation and compliance activities for complex GxP systems across regulated technology environments.

• Lead end-to-end validation activities for GxP systems, including validation plans, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) protocols, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
• Lead computer system validation (CSV) and computerized system assurance (CSA) deliverables across the shop-floor systems lifecycle (L2 to L6), including risk assessments, validation planning, requirements traceability, test strategy and execution, deviation management, final reporting, and release approval
• Apply risk-based validation principles to assess system impact, classify validation requirements, and support compliance with GAMP 5, 21 CFR Part 11, European Union Annex 11, and data integrity requirements
• Drive inspection readiness activities, including gap assessments, mock audits, validation package reviews, and support for regulatory inspections and responses
• Lead corrective and preventive action (CAPA) activities and support validation approaches for artificial intelligence and machine learning-enabled GxP systems and automation testing frameworks, including documentation of governance requirements for non-deterministic outputs

A successful candidate would possess these skills:

• Ability to work independently and collaborate as part of a team
• Effective written and verbal communication skills
• Meticulous attention to detail and quality of work product
• Ability to build and sustain professional relationships
• Ability to lead projects or workstreams
• Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment
• Strong interpersonal skills and professional demeanor
• Ability to meet deadlines
• Ability to provide clear guidance to others

The team

Our Enterprise Operations & Risk offering enables clients to achieve profitable growth and competitive advantage by optimizing "heart of the business" operations. We leverage deep domain expertise to extend enterprise resilience, agility and remediation. Our professionals address client needs which span the organization and impact strategy, operations, performance and reputation.

Qualifications

Required:

• Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience and 6+ years of experience in computer system validation in a life sciences environment, including pharmaceutical, biotechnology, medical device, or clinical environments
• Experience leading validation deliverables for GxP systems and computer system validation (CSV) and computerized system assurance (CSA) activities across the shop-floor systems lifecycle (L2 to L6), including validation plans, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) protocols, summary reports, user requirements specifications, functional specifications, design specifications, traceability matrices, risk assessments, test strategy and execution, deviation management, final reporting, and release approval
• Hands-on understanding of PLC/SCADA architectures, control strategies, alarms
• Experience applying 21 CFR Part 11, European Union Annex 11, GAMP 5, and data integrity requirements, including Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA+) principles
• Experience managing CAPA lifecycle activities, supporting inspection readiness for Food and Drug Administration (FDA) or European Medicines Agency (EMA) audits, and validating artificial intelligence/machine learning (AI/ML)-enabled systems or automation testing frameworks
• Ability to travel 10%, on average, based on the work you do and the clients and industries/sectors you serve.
• Limited immigration sponsorship may be available.

Preferred:

• Experience supporting periodic review programs for validated systems and associated CAPA triggers
• Experience validating cloud or software as a service platforms, including Veeva, ServiceNow, or Salesforce, in a GxP environment
• Experience working in Agile delivery environments with validation activities embedded in sprints
• Experience with AI governance processes, including AI use case tracking, model risk classification, and disclosure requirements for GxP systems

The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $110,700 to $218,300.

You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.