Manager- Product Quality & Safety - Life Sciences & Healthcare

Manager - 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-combined with industry insight-to help clients bring clarity from complexity and accelerate their path to value creation.

Work You'll Do

As a Manager, you will lead the delivery of client engagements and manage teams supporting life sciences clients across Regulatory Affairs and Quality Assurance.

You will bring subject matter expertise, structured problem solving, and strong engagement management to help clients address quality, regulatory, operational, and technology-related challenges across pharmaceutical, biotech, and medical device environments.

This could include:


* Lead client workstreams and teams supporting pharmaceutical and medical device Regulatory Affairs and Quality Assurance strategy, process, operating model, and governance improvements


* Manage quality and regulatory due diligence for mergers and acquisitions, including diligence planning, evidence requests, interview leadership, risk identification, issue synthesis, and diligence reporting


* Lead separation and integration activities for QA/RA functions, including Day 1 readiness, target operating model design, TSA planning, governance, and cutover execution


* Assess quality management system and regulatory compliance gaps across areas such as SOPs, training, deviation management, CAPA, change control, complaints, audits, and inspection readiness


* Lead inspection readiness efforts, including mock inspections, observation response planning, remediation roadmap development, and stakeholder alignment


* Manage QA/RA technology enablement efforts, including requirements definition, future-state process design, vendor evaluation support, validation coordination, testing oversight, training, deployment, and adoption planning


* Lead implementation and optimization of systems such as eQMS, document management systems, learning management systems, complaint handling, CAPA, change control, audit management, supplier quality, and regulatory information management platforms


* Oversee development of client-ready deliverables, including assessments, operating model designs, process flows, requirements, business cases, implementation plans, executive presentations, and steering materials


* Manage project plans, budgets, risks, dependencies, issue resolution, and stakeholder communications across workstreams


* Serve as a day-to-day client leader for assigned workstreams, building trusted relationships and aligning stakeholders on scope, priorities, and decisions


* Coach junior practitioners, review team output for quality, and contribute to the development of D...