Quality Business Analyst (Global Quality Systems)
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The business analyst works with Global Quality to identify software and process related change needs and ensure they are met. Primary focus is on user requirements, solution/change impact assessment, and solution selection/prioritization. The purpose of the job is to identify risks/gaps in new, and current systems and processes. Ensure the business requirements are identified, met, and users understand how they are met. Provide consultation to users in the area of system/process improvements.
• Drive consensus and resolve conflicting interests across the project team members/stakeholders regarding new business system/process designs
• Develop a clear definition of the scope of the business case and ROI including: problem being solved, the business need, scope of the solution, investment to solve problem
• Elicit and document user requirements and ensure that the user understands how the system meets their requirements
• Collaborate in the planning and deployment of new application, as well as enhancements to existing applications
• Facilitate the collection, analysis, and prioritization of enhancement requests
• Facilitate lessons learned sessions
• Define the ‘Data Lifecycle’ for systems and identify associated GxP risks and mitigations
• Document, and analyze the current state of the business process; assess current capabilities
• Create workflow diagrams or other models to visually depict the business process
• Develop scenarios for User Acceptance Testing (UAT) and facilitate end user testing; may perform validation testing
• Update business procedures or business processes, checklists or work aids, or training materials
• Drive associated change control activities
• Other duties as assigned
• Drive continual improvement
• Identify new user needs based on user request trends
• Establish best practices per current industry standards
• Identify overarching/systemic GxP risks and vulnerabilities and mitigations
• Mentor junior business analysts
• B.S. in a science/engineering discipline
• Minimum years of relevant business analysis experience gathering/analyzing/testing requirements: 4-6
• Minimum of 6 years in the biotech/pharma industry
• Prior relevant experience with application of software solutions preferred. Veeva, TrackWise a plus.
• Working understanding of GxP guidelines including 21 CFR Part 11
• Technical Writing Skills – must be able accurately document information.
• Communication Skills – must be able to facilitate working meetings, ask good questions, listen to the answers, and absorb what’s being said.
• Problem-solving Skills – must be able to facilitate a shared understanding of the problem, the possible solutions, and determine the scope of the project.
• Critical Thinking Skills – must be able to evaluate multiple options and help a team settle on a solution.
• Documentation and Specification Skills – must be able to create clear, accurate, and concise documentation.
• Relationship-Building Skills – must be able to forge strong relationships built on trust.
• Self-Managing – must be able to manage the business analysis effort and yourself to commitments and deadlines.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-JG1