Senior Consultant-Digital Quality & Compliance

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.

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

• 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 work streams
• 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

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.

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…