System Test and Validation Lead Organization

As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk, and Forensic team, you will be responsible for…

• Lead end-to-end validation activities for GxP systems, including validation plans, IQ/OQ/PQ protocols, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
• Apply risk-based validation principles to assess system impact, classify validation requirements, and support compliance with GAMP 5, 21 CFR Part 11, and data integrity expectations
• Drive inspection readiness activities, including gap assessments, mock audits, validation package reviews, and support for regulatory inspections and responses
• Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions
• Validate AI/ML-enabled GxP systems and automation testing frameworks, including development of validation approaches for non-deterministic outputs and documentation of AI governance requirements, For individuals assigned and/or hired to work in a remote role, Deloitte is required by law to include a reasonable estimate of the compensation range for this role. This compensation range is specific to a remote role and 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. 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 $95,000 to $145,000.

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.

Deloitte is committed to providing reasonable accommodations for people with disabilities. If you require a reasonable accommodation to participate in the recruiting process, please direct your inquiries to the Global Call Center (GCC) at USTalentCICInbox@deloitte.com.

• 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, Required:
• Bachelor’s degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
• Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
• Experience applying 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements, including Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available principles
• Experience managing CAPA lifecycle activities and supporting inspection readiness for Food and Drug Administration or European Medicines Agency audits
• Experience validating AI/ML-enabled systems, distinguishing deterministic and probabilistic tool behavior, and qualifying or validating 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, Agile Programming Methodologies, Artificial Intelligence (AI), Automation, Biology, Biotech and Pharmaceutical, Cloud Computing, Code of Federal Regulations, Communication Skills, Computer Science, Computer Skills, Computer Systems, Consulting, Corrective and Preventative Action (CAPA) Systems, Customer Support/Service, Customer/Client Research, Data Quality, Detail Oriented, Documentation, Embedded Systems, Emerging Technology, Environmental Sciences, Establish Priorities, FDA (Food and Drug Administration), GxP, Incentive Programs, Information Technology & Information Systems, Interpersonal Skills, Leadership, Maintain Compliance, Medical Equipment, Medical Products, Multitasking, Presentation/Verbal Skills, Process Validation, Regulations, Regulatory Compliance, Requirements Management, Requirements Validation/Verification, Risk, Risk Modeling, Root Cause Analysis, Salesforce.com, ServiceNow, Software Validation, Software as a Service (SaaS), System Test, System Validation, Systems Administration/Management, Systems Analysis, Test Harness, Time Management, Traceability, Use Cases, Validation Plan, Willing to Travel, Writing Skills

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As used in this posting, “Deloitte” means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. Please see https://www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries.