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Invivyd · 10 hours ago

Senior Manager, Quality Control

New Haven, CT

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Invivyd is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases. The Senior Manager, Quality Control will oversee drug substance and drug product testing, manage external testing partners, and ensure compliance with regulatory standards.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Lead and coordinate external testing activities for drug substance (DS) and drug product (DP) release and stability programs, including comprehensive review and approval of protocols, reports, and complete raw data packages to ensure accuracy, compliance, and readiness for regulatory use

Serve as the QC analytical subject matter expert (SME) by providing technical guidance to external partners on analytical method qualification, validation, transfer, and maintenance for DS and DP methods

Perform detailed data trending and statistical analysis of DS/DP release and stability results, proactively identifying shifts in performance and leading timely root-cause evaluation of out-of-trend (OOT) and out-of-specification (OOS) events, including coordination of investigations and implementation of effective corrective/preventive actions

Collaborate cross-functionally to establish, justify, and maintain phase-appropriate DS and DP specifications that align with regulatory expectations and quality standards

Manage and support QC-related quality events, including initiation, assessment, and closure of change controls, deviations, OOS/OOT investigations, CAPAs, and other exceptions, ensuring thorough documentation, timely resolution, and compliance with internal and external requirements

Author, revise, and approve high-quality procedures and documentation that support compliant QC operations

Provide technical expertise for regulatory filings, including preparation and review of QC-related sections for regulatory submissions (INDs, BLAs, and other filings). Support responses to regulatory queries and inspections by providing clear, scientifically sound justifications

Qualification

Biopharmaceutical QC testingManaging external testing partnersAnalytical method qualificationStatistical analysisRegulatory submissionsMS Office proficiencyCommunication skillsAttention to detailProblem-solvingTeam collaboration