Halozyme, Inc. · 22 hours ago
Senior Analyst, Quality Systems
Minnesota - Minnetonka (12500 Whitewater Drive)
Full-time
Onsite
Senior Level
$78K/yr - $115K/yr
5+ years expHalozyme, Inc. is reinventing the patient experience and building the future of drug delivery. The Senior Analyst 1, Quality Systems supports the oversight and continuous improvement of the Quality Management System (QMS) by leveraging data to drive quality intelligence and enhance compliance across various quality system areas.
BiotechnologyMarketingMedical
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
Qualification
Required
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
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.
Company
Halozyme, Inc.
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies.
201-500 employees
H1B Sponsorship
Halozyme, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (2)
2022 (3)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$2.75BKey Investors
Janssen Biotechargenx
2025-11-06Post Ipo Debt· $1.3B
2022-08-15Post Ipo Debt· $500M
2021-02-24Post Ipo Debt· $700M
Leadership Team
Helen Torley
President and Chief Executive Officer
Cortney Caudill
Chief Operating Officer
Recent News
The Motley Fool
2026-01-24
GlobeNewswire
2026-01-12
Company data provided by crunchbase