Senior Compliance Consultant

Senior Compliance Consultant – Quality Agreement SupportLocation: Rensselaer, NY Work Model:Potential Hybrid (Later Phase)Position OverviewWe are seeking a Senior Compliance Consultant with strong expertise in Quality Agreement Support within the biopharmaceutical industry. This role requires an experienced professional capable of independently driving compliance initiatives, coordinating across functions, and ensuring timely execution of quality agreement activities while maintaining regulatory and operational excellence.Key ResponsibilitiesLead end-to-end Quality Agreement lifecycle management, including drafting, review, negotiation, and executionCollaborate with cross-functional teams including Quality, Regulatory, Legal, Supply Chain, and Manufacturing, as well as external partnersEnsure compliance with GMP, FDA, and global regulatory requirementsDrive projects to completion while maintaining quality and timelinesIdentify risks and implement mitigation strategies related to supplier and partner agreementsSupport audits and regulatory inspections by ensuring agreements are inspection-readyTrack and manage agreement status, metrics, and deliverablesProvide guidance on best practices for quality compliance and agreement processesContribute to continuous process improvement initiativesRequired Qualifications7+ years of experience in pharmaceutical or biotechnology industryStrong experience in Quality Systems and Quality AgreementsProven ability to independently lead projects in fast-paced environmentsIn-depth knowledge of GMP regulations (FDA, EMA, ICH guidelines)Strong communication, negotiation, and organizational skillsPreferred QualificationsExperience working with CMOs or supplier quality managementBackground in large-scale biopharma environmentsFamiliarity with QMS and document management systems