Quality Business Analyst (Global Quality Systems)

Location:  Novato, California Category: Quality

Description

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.

Summary:
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 requirementssolution/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.

 

Responsibilities:
 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 needscope of the solutioninvestment 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

Additional Responsibilities:
 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

Education/Experience:
 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.
 

Skills:
 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