Overview In this Senior Consultant role, you drive validation and compliance for complex GxP systems within regulated environments, guiding end-to-end CSV/CSA activities and ensuring data integrity and regulatory alignment. You'll work with cross-functional teams to prepare for inspections and enable AI/ML-enabled validation approaches, contributing to safer, compliant operations. You will operate in a fast-paced setting, coordinating risk-based validation efforts and governance. This is an opportunity to shape quality programs at scale within Deloitte's Regulatory, Risk & Forensic practice.
Compensation / Benefits- discretionary annual incentive program
Responsibilities- Lead end-to-end validation for GxP systems including IQ/OQ/PQ, reports, specifications, and traceability matrices
- Manage CSV and CSA deliverables across shop-floor lifecycle (L2-L6) with risk assessments, test strategy, and release approvals
- Apply risk-based validation to ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+)
- Lead inspection readiness activities: gap assessments, mock audits, and regulatory responses
- Oversee CAPA activities and validation approaches for AI/ML-enabled GxP systems and automation testing
- Provide clear guidance, lead projects/workstreams, and manage multiple tasks in a dynamic environment
Key requirements- 6+ years of experience in computer system validation in life sciences (pharma, biotech, medical device, or clinical environments)
- Experience leading validation deliverables for GxP systems and CSV/CSA across the shop-floor lifecycle (L2-L6)
- Hands-on understanding of PLC/SCADA architectures, control strategies, and alarms
- Experience applying 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles
- Experience managing CAPA lifecycle activities and supporting FDA/EMA inspection readiness; AI/ML-enabled validation experience
- Ability to travel 10% and willingness for limited immigration sponsorship
- independent work style
- effective written and verbal communication
- attention to detail and quality
- PLC/SCADA architectures
- GxP validation
- CSV and CSA lifecycle management
