Quality Management System Analyst

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. In 2023, Lantheus had more than $1B in revenues, led by sales of imaging agents for cardiac ultrasound and for prostate cancer.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of role

The Quality Business Analyst is responsible for understanding business requirements related to quality management, assessing processes, and supporting the implementation and ongoing management of TrackWise Digital solutions. This role will collaborate closely with stakeholders across various departments to ensure alignment of TrackWise Digital functionalities with business needs. This role requires strong analytical skills, a deep understanding of TrackWise Digital capabilities, and the ability to translate business requirements into technical specifications.

Key Responsibilities/Essential Functions

TrackWise Digital Data Management:

• Manage and maintain data integrity within the TrackWise Digital QMS, ensuring accurate and consistent data entry across the system.
• Develop and implement data validation rules and checks to maintain high data quality standards.
• Configure and manage TrackWise data fields, workflows, and reporting tools to meet business requirements.

Data Analysis and Reporting:

• Establish, maintain, and support monitoring Quality KPIs across all Quality systems.
• Analyze data to identify trends, patterns, and areas for improvement in quality processes.
• Create and maintain dashboards and reports that provide actionable insights to stakeholders.
• Support the development of KPIs and metrics that align with business objectives and regulatory requirements.

Data Extraction and Integration:

• Extract, transform, and load (ETL) data from various systems or data warehouses for further analysis.
• Collaborate with IT and data teams to integrate QMS data with other enterprise systems and tools.
• Ensure seamless data flow and accuracy between QMS and other systems.
• Identify opportunities to improve data management practices across enterprise systems.
• Recommend and implement system enhancements that increase data accuracy, accessibility, and usability.

Requirements Gathering & Analysis:

• Work with stakeholders to gather data-related business requirements and translate them into technical specifications.
• Conduct data gap analysis and recommend system enhancements to improve data capture, reporting, and analysis.
• Document data processes, workflows, and procedures to ensure clarity and consistency.

Continuous Improvement:

• Utilizing Lean Six Sigma methods to drive process improvements and improve product quality.
• Analyze and understand key processes and their data trends and offer insights and recommendations.
• Identify opportunities for enhancing processes, data quality, addressing issues through error detection, correction, and process control.

User Support and Training:

• Provide training and support to end-users on data-related functionalities.
• Develop user guides and documentation to support data entry, reporting, and analysis tasks.
• Troubleshoot data-related issues and provide solutions to ensure accurate data management.

Basic Qualifications

• Bachelor's degree in business administration, Information Systems, Analytics or a related field.
• 3-5 years of experience as a Business Analyst or similar role, specifically with TrackWise Digital or other quality management systems.
• Experience in managing and analyzing data within a regulated environment (e.g., pharmaceuticals, medical devices, biotech).
• Strong understanding of quality management processes and regulatory compliance requirements (e.g., FDA, ISO).
• Experience in gathering and documenting business requirements, process flows, and system design specifications.
• Ability to communicate effectively with technical and non-technical stakeholders.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• Proven experience in data extraction, transformation, and reporting.

Other Requirements

• Strong proficiency in data analysis tools (e.g., SQL, Excel, Power BI) and data management best practices.
• Ability to translate business needs into data-driven solutions.
• Strong problem-solving skills with the ability to analyze complex data sets.
• Experience with data integration and ETL processes is a plus.

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States.