Senior Manager, Quality Control Data Analyst

Summary:

Vaxcyte has an exciting opportunity for a Senior Manager, Quality Control Data Analyst to join our QC organization to act as a bridge between our technical QC Operations team and Business teams.  This individual will be responsible for the collection, evaluation, interpretation, and visualization of complex datasets to provide actionable insights that drive technical and business decisions. Key responsibilities include creating reports, maintaining databases, and using tools to identify trends, initiate quality events if needed, improve efficiency, and support definition of acceptance criteria as well as strategic planning.

Essential Functions:

• Work closely with the analytical sub teams and other functions within Analytics, Process Development, Quality Assurance, Operations, and Regulatory functions.
• Accountable for data integrity, accuracy, and reliability as well as that datasets are assessed in a timely manner and meet quality and regulatory standards to ensure secure and uninterrupted supply of Vaxcyte’s innovative therapies.
• Develop, implement, and maintain leading-edge analytics systems, taking complicated problems and building simple frameworks.
• Evaluate internal systems for efficiency, problems, and inaccuracies with regard to data collection and evaluation, and develop and maintain processes and SOPs for handling, evaluation, and visualization of complex data sets.
• Lead activities in QC Operations with regards the data warehousing and data mining programs underway (VaxData).
• Create and maintain rich interactive visualizations through data interpretation and analysis, with reporting components from multiple data sources.
• Define and implement data acquisition and integration logic, selecting an appropriate combination of methods and tools within the defined technology stack to ensure optimal scalability and performance of the solution.
• Develop and maintain databases by acquiring data from primary and secondary sources, and build scripts that will make our data evaluation process more flexible or scalable across datasets.
• Implement, and maintain robust quality control systems that encompass data mining, analysis, and visualization
• Follow prescribed systems for data management, including secure storage, retrieval, and retention of QC data and documentation are in place. Ensure that all testing activities are well-documented and comply with Good Documentation Practices (GDP).
• In partnership with the analytical subteams and analytical science and technology, oversee data collection, evaluation and visualization for in-process and release data in order to support monitoring the analytical control strategy and related acceptance criteria.
• Identify trends to initiate quality events and respective investigations through analysis of complex datasets.
• Review and approval of analytical data, test reports, and certificates of analysis (CoAs) generated by contract laboratories to verify accuracy, completeness, and compliance with specifications for both in-process and release testing.
• Act as point of contact with IT for QC operations.
• Support investigations and deviations, out-of-specification (OOS), out-of-trend (OOT), out-of-expectation (OOE) results, laboratory incidents, and customer complaints collaborating with internal stakeholders to implement corrective and preventive actions (CAPAs) as a data Subject Matter Expert.
• Writing, review and approval of documents related to Quality Control, Computer System Validation, and GAMP5 to ensure compliance with applicable regulatory and industry standards.
• Work directly with managers and users to gather requirements, provide status updates, and build relationships.

Requirements: 

Bachelor’s degree (or equivalent) in biology, biochemistry or other related science with 8+ years of experience in biotechnology/pharmaceutical industry and 3+ years of experience as data analyst in data science/statistics. Other combinations of education and/or experience may be considered.

• Proven analytics skills, including mining, evaluation, and visualization.
• Technical writing experience in relevant areas, including queries, reports, and presentations.
• Expert level knowledge of the standard MS suite of programs (Excel, Word, VBA, Teams, Access).
• Strong SQL, with aptitude for learning other analytics tools.
• Experience with database and model design and segmentation techniques.
• Practical experience in statistical analysis through the use of statistical packages SPSS, and SAS.
• Comprehensive knowledge in cGDP and experience in multi-national regulations.
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making and continuous improvement.
• Experience in Quality Control, especially late stage or commercial.
• Proven success in a collaborative, team-oriented environment.
• Relentless focus and passion around process improvements (efficiency and automation).