Senior Analyst, Quality Systems

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Welcome to an inspired career.

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. Thats why we need youto 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 youll be part of a culture that welcomes diversity thinks differently to solve problems works collaboratively as one team and delivers meaningful innovations that impact peoples 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 intelligencedeveloping 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 youll 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

To succeed in this role youll need:

• Bachelors 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 In return we offer you:
• 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 impacton your career the work you do and patients lives.

The most likely base pay range for this position is $78K - $115K per year. Several factors such as experience tenure skills and particular business needs will determine an individuals exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses sales incentives and equity awards.

Halozyme Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race color religion sex sexual orientation gender identity national origin age protected veteran or disabled status or genetic information.

Accessibility and Reasonable Accommodations:

Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability contact Human Resources at .

To view all our open positions please visit our career page. Additionally our benefit offerings can be found here.