Senior Consultant – Product Quality & Safety – Life Sciences & Healthcare

Senior Consultant – Product Quality & Safety – Life Sciences & Healthcare

Strategy, Growth, and Transformation | Functional and Operational Strategy and Transformation

Same job available in 9 locations

Boston, Massachusetts, United States Chicago, Illinois, United States Costa Mesa, California, United States Los Angeles, California, United States Morristown, New Jersey, United States New York, New York, United States Philadelphia, Pennsylvania, United States San Francisco, California, United States Stamford, Connecticut, United States

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Senior Consultant – Product Quality & Safety - Life Sciences & Healthcare Enterprise Operations & Risk 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 organizations. 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 The Senior Consultant is responsible for helping to deliver related client projects, and in doing so to continue to grow professionally in the areas of subject matter expertise and consulting engagement administration. A Senior Consultant must understand how Commercial and Medical activities and related messaging/content are influenced by Regulatory/Health Authority requirements. This could include: Support clients in pharmaceutical and medical device Regulatory Affairs and Quality Assurance strategy, operating model, process, and governance improvements Conduct quality and regulatory due diligence for mergers & acquisitions (M&A), including risk identification, evidence requests, and diligence readouts (e.g., compliance history, inspection readiness, quality system maturity) Support separation and integration activities for QA/RA, including Day 1 readiness, target operating model, transition service agreement (TSA) considerations, and cutover planning Assess and remediate quality management system (QMS) and regulatory compliance gaps (e.g., SOPs, training, deviation management, corrective and preventive actions (CAPA), change control, complaints) Support inspection readiness planning and execution (e.g., mock inspections, observation response planning, compliance remediation roadmaps) Help design and implement RA/QA technology enablement, including requirements definition, vendor selection support, process design, testing/validation coordination, and deployment/adoption planning Support implementation and optimization of systems such as electronic QMS (eQMS), document management systems (DMS), learning management systems (LMS), complaint handling, CAPA, change control, audit management, supplier quality, and regulatory information management (RIM) platforms Develop client-ready deliverables (assessments, workflows, requirements, business cases, implementation plans, and executive communications) and manage workstream risks, dependencies, and stakeholder alignment Additional expectation is to continually build detailed subject matter expertise and assist in the buildout of service offerings in the area of Commercial and Medical Content Management 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