Consultant - Product Quality & Safety - Life Sciences & Healthcare

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

Work You'll Do

As a Consultant, you will support the delivery of client projects while continuing to grow your subject matter expertise and consulting skills.

You will work with teams helping life sciences clients address quality, regulatory, operational, and technology-related challenges across pharmaceutical, biotech, and medical device environments.

This could include:


* Support clients in pharmaceutical and medical device Regulatory Affairs and Quality Assurance strategy, process, operating model, and governance improvements


* Assist with quality and regulatory due diligence for mergers and acquisitions, including document review, evidence gathering, interview support, risk tracking, and diligence summaries


* Support separation and integration activities for QA/RA functions, including Day 1 planning, governance coordination, TSA support, and cutover readiness activities


* Help assess quality management system and regulatory compliance gaps across areas such as SOPs, training, deviation management, CAPA, change control, complaints, and audit readiness


* Support inspection readiness efforts, including mock inspection preparation, issue tracking, and remediation planning support


* Assist with QA/RA technology enablement efforts, including business requirements gathering, process documentation, test script development, validation support, training coordination, and deployment activities


* Support 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


* Develop portions of client-ready deliverables, including assessments, process flows, requirements, status reports, business cases, and implementation plans


* Track project activities, risks, dependencies, and action items, and support stakeholder coordination across workstreams


* Continue building subject matter knowledge in Regulatory Affairs, Quality Assurance, and Commercial/Medical Content Management

The successful candidate would possess these skills

• 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...