Andrew Bursick
Glastonbury,USA
Summary
Strategic and results-driven Quality Assurance professional with 8+ years of experience supporting GxP compliance in global pharmaceutical settings. Proven success building quality culture across cross-functional teams including Clinical Development, Regulatory Affairs, and Supply Chain. Skilled in GxP compliance, regulatory inspection readiness, risk-based quality management, and CAPA lifecycle oversight. Demonstrated ability to foster continuous improvement, operational excellence, and proactive risk mitigation in high-stakes environments.
Overview
8
8
years of professional experience
Work History
Manager, Quality Assurance
Pfizer
07.2022 - Current
- Serve as QA lead for clinical manufacture operations, providing strategic GxP oversight for API, DPI, and FDP activities at CMOs.
- Collaborate with Clinical Development and Regulatory stakeholders to ensure quality and compliance across program lifecycles.
- Author and review regulatory submissions and responses with a focus on quality impact and risk mitigation.
- Conduct root cause analyses and lead resolution of quality investigations, ensuring CAPA effectiveness and sustainability.
- Support integration planning for acquired materials, conducting risk assessments and developing disposition strategies.
- Actively participate in Quality Governance meetings to align quality strategies across clinical programs.
Manager, Global Clinical Supplies (GCS) Inspection Readiness Lead
Pfizer
09.2021 - 07.2022
- Directed global inspection readiness strategy for GCS teams across multiple programs and countries.
- Coordinated cross-functional preparation, SME training, and response management for audits and regulatory inspections.
- Facilitated lessons-learned debriefs, promoting a culture of ongoing compliance, transparency, and quality improvement.
- Maintained and enhanced the GCS Quality Management SharePoint, supporting knowledge sharing and process standardization.
- Developed standardized audit tools and templates for tracking, SME guidance, and document control.
- Executed inspection risk mitigation plans and closed compliance gaps across global study portfolios.
Senior Associate Quality Operations
Pfizer
03.2020 - 09.2021
- Provided QA oversight for GMP manufacturing and testing of Investigational Medicinal Products.
- Conducted internal audits and supported external inspections, leading remediation of findings and systemic improvements.
- Led initiatives to streamline batch record review, cleaning validation, and documentation accuracy.
- Provided QA support for complex deviations and non-conformances in collaboration with manufacturing and analytical teams.
Project Coordinator
Almac Group
11.2019 - 03.2020
- Monitored drug product shipments to clinical sites and depots, ensuring inventory accuracy and escalating discrepancies to the Supply Chain Lead.
- Maintained and reconciled supply chain reports, analyzing actual vs. planned quantities to support demand forecasting.
- Collaborated with Supply Chain Leads to develop and implement clinical supply strategies, including scheduling, quantities, and packaging operations.
- Prepared and verified inspection readiness documentation and reviewed clinical supplies records to ensure compliance with Good Documentation Practices (GDPs) before Trial Master File (TMF) submission.
Continuous Improvement Specialist
SCA Pharma
09.2018 - 11.2019
- Led deviation investigations, root cause analysis, and CAPA planning for sterile product manufacturing.
- Authored risk assessments and collaborated on regulatory inspection responses (FDA, State Boards of Pharmacy).
- Designed and implemented SOPs and continuous improvement initiatives to enhance operational compliance.
- Implemented visual management tools and Lean Six Sigma methodologies to track key performance indicators (KPIs) and drive department-wide process enhancements.
Production Planner
SCA Pharma
10.2017 - 09.2018
- Developed master production schedules aligned with supply chain forecasts and quality requirements.
- Led inventory audits and collaborated with QA to align scheduling with regulatory expectations.
- Interfaced with procurement and manufacturing teams to resolve material constraints, improving on-time delivery and minimizing production delays.
Education
Doctor of Medical Sciences - Patient Safety
Northeastern University
04.2025
Master of Science - Regulatory Affairs for Drugs, Biologics, and Medical Devices, Regulatory Compliance
Northeastern University
04.2021
Bachelor of Arts - Public Health
University of South Florida
12.2017
Skills
- GCP/GMP/GxP Compliance Clinical Development QA CAPA Lifecycle Oversight
- Quality Risk Management KQI/KRI Identification Regulatory Inspection Readiness
- Cross-functional Stakeholder Engagement Root Cause Analysis SOP Development
- Continuous Improvement Issue Trending & Analysis Quality Governance & Audit Support
- Regulatory Submission Review Clinical Trial Quality Oversight Quality Systems
Technical Skills
SAP | LIMS | MasterControl | Trackwise | Axis 360 | Veeva Vault | GDMS | Microsoft Suite
Timeline
Manager, Quality Assurance
Pfizer
07.2022 - Current
Manager, Global Clinical Supplies (GCS) Inspection Readiness Lead
Pfizer
09.2021 - 07.2022
Senior Associate Quality Operations
Pfizer
03.2020 - 09.2021
Project Coordinator
Almac Group
11.2019 - 03.2020
Continuous Improvement Specialist
SCA Pharma
09.2018 - 11.2019
Production Planner
SCA Pharma
10.2017 - 09.2018
Master of Science - Regulatory Affairs for Drugs, Biologics, and Medical Devices, Regulatory Compliance
Northeastern University
Doctor of Medical Sciences - Patient Safety
Northeastern University
Bachelor of Arts - Public Health
University of South Florida
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