Senior Manager, Quality Control Data Analyst
$166,000–$194,000 year
On-site · San Carlos, California, United States
Job Summary
Senior Manager, Quality Control Data Analyst to bridge QC Operations and Business teams. Responsible for collecting, evaluating, interpreting, and visualizing complex datasets to provide actionable insights that drive technical and business decisions. Key duties include creating reports, maintaining databases, identifying trends, initiating quality events as needed, improving efficiency, supporting acceptance criteria definition, and aiding strategic planning. Collaborates across Analytics, Process Development, Quality Assurance, Operations, and Regulatory functions; ensures data integrity, regulatory compliance, GDP, and secure uninterrupted supply of therapies. Develops and maintains analytics systems, data acquisition/integration logic, data warehouses, data mining programs (e.g., VaxData), and rich interactive visualizations from multiple data sources; writes and approves QC documents including Computer System Validation and GAMP5 related artifacts; supports CAPAs and investigations for OOS/OOT/OOE; serves as point of contact with IT for QC operations; contributes to SARs/CoAs review and approval; reports to Director, QC Business Operations; located in San Carlos, CA.
Required Qualifications
- Bachelor’s degree (or equivalent) in biology, biochemistry or related science
- 8+ years of experience in biotechnology/pharmaceutical industry
- 3+ years of experience as data analyst in data science/statistics
- Proven analytics skills (mining, evaluation, visualization)
- Technical writing experience (queries, reports, presentations)
- Expert level knowledge of Excel, Word, VBA, Teams, Access
- Strong SQL; ability to learn other analytics tools
- Experience with database and model design and segmentation techniques
- SPSS and SAS statistical packages experience
- Knowledge of cGDP and multinational regulations
- Strong analytical and problem-solving abilities; data-driven decision making
- Experience in Quality Control, especially late stage or commercial
- Proven collaboration in team environments
- Process-improvement and automation focus
- Reporting to: Director, QC Business Operations
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