Consultant - Product Quality & Safety - Life Sciences & Healthcare

About the role

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.

Responsibilities

• Support clients in pharmaceutical and medical device Regulatory Affairs and Quality Assurance strategy, process, operating model, and governance improvements
• Aid in 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
• Assist in assessing 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

Qualifications

• Bachelor’s degree required
• 2+ years of experience focused on Life Sciences in a consulting and/or industry role
• Experience or exposure to the use of data, analytics, and/or AI-enabled tools to support business processes or decision-making
• Foundational experience in pharmaceutical QA/RA (e.g., GMP, quality systems, compliance support) and/or medical device QA/RA (e.g., design controls, risk management, post-market processes)
• Working knowledge of common regulatory and quality requirements applicable to pharmaceutical and/or medical device organizations
• Experience supporting the translation of regulatory and quality requirements into business processes, documentation, or controls
• Experience supporting project delivery in areas such as compliance remediation, process improvement, system implementation, diligence, or integration planning
• Familiarity with quality and regulatory systems and capabilities such as document control, training, deviations, CAPA, change control, audits, complaints, supplier quality, and/or submission or product registration data management
• Experience supporting data analysis, reporting, dashboards, KPI tracking, or process monitoring
• Experience in project management, PMO support, or workstream coordination
• Ability to manage multiple assignments and work effectively in a deadline-driven environment
• Strong attention to detail and ability to produce polished, client-ready deliverables
• Strong written and verbal communication skills and ability to work effectively in cross-functional teams

Preferred

• Experience in the pharmaceutical, biotech, and/or medical device industries
• Experience supporting eQMS, RIM, DMS, LMS, or related quality/regulatory technology initiatives
• Experience with compliance assessments, inspection readiness, remediation, or QA/RA process improvement

Pay

$88,700 - $170,900

Schedule

Full-time