Jacqueline Zarzycki
Alnylam Pharmaceuticals Inc.
5
years of professional experience
Quality Assurance professional with 5+ years of experience in the biotechnology industry specializing in supplier quality management, quality systems, and analytics. Proven success managing supplier relationships, executing risk-based audit programs, overseeing supplier performance metrics, and driving timely resolution of quality events. Recognized for independently developing technology-driven solutions that improve operational efficiency, strengthen inspection readiness, and enhance supplier lifecycle management through data analytics, automation, and cross-functional collaboration.
Work History
QA Specialist, Digital Quality Compliance
11 Months- Design and maintain external audit tracker supporting all stages of supplier audit execution, ensuring timely completion and compliant record closure.
- Enhance enterprise Quality Dashboard to provide actionable insights for Quality and partner organizations.
- Lead Quality data governance initiatives by documenting system data flows and creating comprehensive data dictionaries to improve traceability and data integrity.
- Collaborate with Quality leadership and business stakeholders to increase visibility into key organizational performance metrics.
Senior QA Associate, GCP/GLP Vendor Oversight
1 Year 6 Months- Executed annual GCP/GLP supplier audit program, conducting supplier risk assessments, audit planning, budget tracking, scheduling, scope development, CAPA oversight, and deviation management to ensure compliance and quality standards.
- Acted as primary Quality liaison for Contract Research Organizations (CROs), coordinating inspection readiness, resolving quality issues, and negotiating Quality Agreements to align operations with regulatory requirements.
- Developed an automated supplier risk assessment methodology that improved consistency, traceability, and regulatory compliance.
- Designed and implemented a Power BI-based Vendor Database serving as an interactive Approved Supplier Listing used by over 120 employees.
- Created Smartsheet automation to notify stakeholders of supplier deviations impacting active clinical programs.
QA Associate, R&D / Pharmacovigilance
2 Years 2 Months- Oversaw GCP and GVP Quality Events, ensuring timely record closure and facilitating root cause investigations to enhance compliance.
- Prepared teams for regulatory inspections through comprehensive document reviews, training verification, system access assessments, and coordinated mock inspections to ensure readiness.
- Developed customized eQMS reports supporting Quality leadership and department performance monitoring.
Education
Master of Science - Computer Information Systems
Bachelor of Arts - Biomathematics
Skills
Supplier Lifecycle Management
Vendor Risk Assessment
Quality Systems
Audit Management
Data Analytics & Reporting
Process Automation
Timeline
QA Specialist, Digital Quality Compliance
Alnylam Pharmaceuticals Inc.
09.2025 - CurrentRead More
Senior QA Associate, GCP/GLP Vendor Oversight
Alnylam Pharmaceuticals Inc.
03.2024 - 09.2025Read More
QA Associate, R&D / Pharmacovigilance
Alnylam Pharmaceuticals Inc.
01.2022 - 03.2024Read More
Boston University
Master of Science from Computer Information Systems
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Rutgers University
Bachelor of Arts from Biomathematics
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