Jinney Alcindor
Senior Manager, Patient Support Programs Governance & Quality @Alexion Pharmaceuticals, Inc.
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WORK HISTORY
Senior Manager, Patient Support Programs Governance & Quality @Alexion Pharmaceuticals, Inc.
Scope & Leadership: Lead U.S. PSP governance and quality oversight for the rare-disease portfolio; serve as Governance Board Lead and main point of contact for FDA inspections and PSP audits.•Strategy & Governance: Built governance frameworks for PSP onboarding, vendor oversight, and lifecycle management; Managed and updated SOP language and monitoring controls aligned to FDA, REMS, GxP, and PV requirements.•Quality Program: Launched Patient Services Quality Program with monthly call audits and calibrations; instituted performance trending and targeted training to improve compliance and documentation integrity.•Vendor Management: Oversee multiple PSP vendors; manage MSAs/SOWs/SOPs/Quality Agreements; drive KPI monitoring, corrective actions, and continuous improvement.•PV Oversight: Ensure accurate/timely AE, SAE, product complaints, and special situation reporting per FDA timelines; monitor PV KPIs and training completion to identify risks.•Audits & Inspections: Primary liaison for internal and third-party PSP audits; lead deliverables, root-cause analyses, remediation plans and timely close-out. Support FDA inspection readiness.•Cross-Functional Collaboration: Partnered with Patient Safety, Quality, Medical Affairs, Legal, Compliance, and Commercial teams to streamline cross-functional program rollouts, enhance operational governance workflows, and ensure regulatory alignment across initiatives.•AI & Automation: Leveraged Maestro QA to automate AE identification and call-audit requirements, improving accuracy and reducing manual review.
EDUCATION
University of Central Florida
Bachelor of Science - BS, Health Service Administration
Valencia College
Associate of Arts - AA, General Studies
Sollers College
Master of Science - MSc, Advance Drug Safety and Pharmacovigilance
SKILLS
ABOUT JINNEY ALCINDOR
Strategic governance leader with 10+ years of experience across rare-disease and specialty pharmacyenvironments. Proven success operating compliant Patient Support Programs (PSPs), strengthening vendor oversight, and optimizing regulatory compliance for pharmacovigilance/quality systems. Proven record leading FDA inspection readiness, establishing governance frameworks, and leveraging AI to enhance accuracy and reduce manual effort. Trusted cross-functional partner who drives operational excellence, risk mitigation, and measurable outcomes.LEADERSHIP HIGHLIGHTSGovernance Board Lead for U.S. PSPs; primary liaison for FDA inspections and PSP audits; instituted end-to-end governance and quality oversight.Designed and implemented PSP governance frameworks (onboarding, vendor lifecycle, monitoring), reducing compliance gaps and audit observations year over year.Established a Patient Services Quality Program with monthly call audits, calibrations, performance trending, and targeted training, improving compliance and documentation integrity.Leveraged Maestro QA AI capabilities to automate identification of AEs and audit requirements, boostingaccuracy and decreasing manual review burden.Directed vendor performance management (MSAs, SOWs, SOPs, Quality Agreements); led deviations, quality events, risk assessments, and CAPAs using Veeva Vault and TrackWise.Delivered PV training (new-hire and annual) to internal teams and external PSP vendors; monitored/trended PV KPIs to proactively manage risk.
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