Remediation Program Lead

OverviewOur biotech client is seeking a senior-level consultant to lead and support a complex remediation initiative tied to agency observations/warning letter activities across CMO operations. This individual must combine strong project management capabilities with hands-on remediation expertise and executive-level communication skills.The consultant will work cross-functionally with internal leadership, external CMOs, and quality/manufacturing stakeholders to drive remediation execution and inspection readiness efforts ahead of key regulatory timelines.Key ResponsibilitiesLead and manage remediation activities associated with agency observations and/or warning letter commitmentsBuild and manage integrated remediation project plans, timelines, and execution trackingFacilitate cross-functional meetings and drive accountability across internal teams and external CMOsDevelop executive-level communications, dashboards, and one-page status summaries for leadership updatesReview remediation plans, CAPAs, and supporting documentation for adequacy, practicality, and regulatory alignmentPartner directly with CMOs to assess execution strategies and ensure remediation activities are progressing appropriatelyProvide strategic guidance on inspection readiness across manufacturing and testing sitesSupport commercialization readiness initiatives where applicableHelp drive alignment across multiple stakeholders and functionsRequired Background/ExperienceBS degree minimum5+ years of medical device industry experienceDirect experience leading or supporting FDA/agency remediation programs and warning letter remediation activitiesStrong project management experience within regulated life sciences environmentsDemonstrated ability to operate in highly visible, cross-functional environments with senior leadership exposureExperience interacting directly with CMOs and external manufacturing partnersAbility to critically evaluate remediation strategies and determine execution feasibilityExperience driving remediation execution beyond simple gap assessments or CAPA authorshipStrong executive presence and communication skillsPreferred ExperienceCombination product experience strongly preferredPrior inspection readiness experience highly desiredExperience supporting global manufacturing networks and external testing labs preferredLocal to New Jersey preferred, though not requiredEngagement DetailsStart: June 2026Duration: Through mid-to-late September 2026Hours: The client anticipates full-time, ~40 hours/weekLocation: Remote is acceptable, although local to NJ office is preferredTravel:Travel to New Jersey officePotential travel to CMO site in FranceInternational travel helpful but not mandatoryAdditional remediation/CAPA support may extend to other CMO sites and testing laboratories