Senior Analyst, Quality Systems

Halozyme, Inc. • Minnetonka, MN

1d

About The Position

At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team – we rise by lifting others up and believe in the power of working together for the collective win. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive. Join us as a Senior Analyst 1, Quality Systems, and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives. How you will make an impact The Senior Analyst 1, Quality Systems supports the oversight and continuous improvement of our Quality Management System (QMS). This position focuses on leveraging data to drive quality intelligence—developing and standardizing key metrics, building dashboards, and performing trend and gap analyses to identify opportunities for improvement. Working across multiple quality system areas, including CAPA, Deviation, and Change Control, the Senior Analyst transforms complex data into actionable insights that enhance compliance, streamline processes, and strengthen overall quality performance. In this role, you’ll have the opportunity to: Support the maintenance and enhancement of the QMS to ensure compliance with cGMP, FDA, ISO, and other applicable standards Collect, analyze, and interpret quality data to identify trends, gaps, and opportunities for improvement across a variety of quality system areas including CAPA, Deviation, and Change Control processes Design, standardize, and monitor key Quality Metrics to measure system health and performance Collaborate with MasterControl System Administrators to build and maintain interactive dashboards that provide leadership with real-time visibility into QMS performance and compliance indicators Perform deep-dive statistical analyses to detect early signals of systemic issues and recommend proactive corrective actions Lead or support continuous improvement initiatives to streamline workflows, reduce waste, and optimize quality processes based on data-driven insights Oversee and compile data for Quality Metrics meetings and Management Review meetings to ensure accurate reporting and informed decision-making Partner with quality teams, process owners, and leadership to communicate findings, influence decisions, and drive standardization and simplification Present data insights and improvement recommendations to senior management in a clear, actionable format; build strong relationships across all organizational levels Promote a culture of quality awareness and continuous improvement through data transparency and proactive problem-solving

Requirements

• Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, or a related field required with 5+ years of experience in Quality Assurance or Quality Systems within a biotech, diagnostic, or therapeutic environment (An equivalent combination of experience and education may be considered)
• Strong foundation in regulatory compliance and quality system processes (CAPA, Deviation, Change Control)
• Deep understanding of FDA 21 CFR Part 820, Part 11, ISO 13485, and related regulations and standards
• Proficiency in electronic Quality Management Systems (eQMS) such as MasterControl, Veeva or TrackWise
• Skilled in data visualization and dashboard development

Responsibilities

• Support the maintenance and enhancement of the QMS to ensure compliance with cGMP, FDA, ISO, and other applicable standards
• Collect, analyze, and interpret quality data to identify trends, gaps, and opportunities for improvement across a variety of quality system areas including CAPA, Deviation, and Change Control processes
• Design, standardize, and monitor key Quality Metrics to measure system health and performance
• Collaborate with MasterControl System Administrators to build and maintain interactive dashboards that provide leadership with real-time visibility into QMS performance and compliance indicators
• Perform deep-dive statistical analyses to detect early signals of systemic issues and recommend proactive corrective actions
• Lead or support continuous improvement initiatives to streamline workflows, reduce waste, and optimize quality processes based on data-driven insights
• Oversee and compile data for Quality Metrics meetings and Management Review meetings to ensure accurate reporting and informed decision-making
• Partner with quality teams, process owners, and leadership to communicate findings, influence decisions, and drive standardization and simplification
• Present data insights and improvement recommendations to senior management in a clear, actionable format; build strong relationships across all organizational levels
• Promote a culture of quality awareness and continuous improvement through data transparency and proactive problem-solving

Benefits

• Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.
• A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level