Senior Manager, Quality Control Data Analyst

Responsibilities

• Act as a bridge between technical QC Operations and Business teams by collecting, evaluating, and visualizing complex datasets.
• Develop, implement, and maintain leading-edge analytics systems and robust quality control systems.
• Create and maintain interactive visualizations and reports from multiple data sources to drive actionable insights.
• Lead data warehousing and data mining programs (VaxData) within QC Operations.
• Ensure data integrity, accuracy, and compliance with cGDP and multi-national regulatory standards.
• Identify trends to initiate quality events, investigations, and corrective/preventive actions (CAPAs).
• Review and approve analytical data, test reports, and certificates of analysis (CoAs) from contract laboratories.
• Support investigations into OOS, OOT, and OOE results, as well as laboratory incidents and customer complaints.
• Write, review, and approve documents related to Quality Control, Computer System Validation, and GAMP5.

Requirements

• Bachelor’s degree in biology, biochemistry, or a related science.
• 8+ years of experience in the biotechnology or pharmaceutical industry.
• 3+ years of experience as a data analyst in data science or statistics.
• Expert-level proficiency in MS Excel, Word, VBA, Teams, and Access.
• Strong SQL skills with the ability to learn new analytics tools.
• Practical experience with statistical packages such as SPSS and SAS.
• Comprehensive knowledge of cGDP and multi-national regulations.
• Experience in Quality Control, particularly in late-stage or commercial environments.
• Proven ability in data mining, evaluation, and technical writing.

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. We are guided by core values of rethinking convention, aiming high, leading with heart, and modeling excellence.