Sr Business Analyst, IT Quality Systems - Ireland
- Our company 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.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- By providing a foundation for all operations company wide, our company’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases.
- Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
Lead Business Analyst, IT Quality Systems
- The Business Analyst, IT Quality Systems works closely with the business and technical teams and is a major contributor to the requirements specification deliverable, writes the business and functional requirements for IT Quality Systems. This person has a good understanding of validated enterprise Quality Management Systems and Controlled Document Systems, and ensures that there is integration between business and technology.
- The Position will maintain full time engagement with the Technical Operations business unit (Quality, Manufacturing, Facilities, etc), the Development Sciences unit, and the Corporate unit, to review Quality Systems related business processes in order to gain a complete understanding of current procedures, identify improvements, document those processes, and connect the business to technology groups in the organization.
- Will be an integral part of IT global Dedicated Business Solutions and Information Managing strategies, with responsibility for creating detailed Requirements Documents and translating into functional specifications.
- The position will capture business problem statements and map business processes to drive selection. Will also manage Quality System configurations/deployments and user acceptance.
- Working with project teams made up of business users and system owners, as well as working independently, this position will ensure system and process user requirements are met and tasks are accomplished within defined timeframes at the highest quality with attention given to detail and scalability.
Strategic / Governance:
- Identify areas of improvement with a focus on business systems and translate these opportunities into technical solutions
- Partner with business to develop long-range business process and system roadmaps to enable constant evolution and deployment of technology to help the business mature and scale.
- Balances business requirements with technical feasibility. Recommends changes in business process, development, maintenance and system standards.
- Manage ongoing relationship with business partner to drive satisfaction with IT
- Ensures all activities are conducted with orientation to the customer and are facilitated with speed, accuracy, quality, and a service attitude conducive to good
Operational / Tactical:
- Works with business stakeholders to understand, analyze, evaluate the business requirements and translate them into functional and non-functional requirements
- Critically evaluates information gathered from multiple sources and reconciles conflicts
- Dissects high-level information into details and is able to communicate details in a manner understood by relevant audiences
- Collaborate cross-functionally to drive process improvement and document business processes
- Collaborate within IT to understand enterprise platform roadmaps and maximize usage of our existing technologies.
- Acts as a liaison between client area and technical organization by planning, conducting, and directing the analysis of highly complex business problems to be solved with automated systems
- Provides technical assistance in identifying, evaluating, and developing systems and procedures that are cost effective and meet business requirements
- Participate on change control boards and design review committees
- Perform fit / gap assessments and providing solution options with impact assessments
- Assist with / participate on teams that support recurring events: close, annual year end, etc.
- Work with external application developers or system integrators to implement functional and reporting applications
- Provide application technical support. Investigate and resolve issues. Liaise with software vendors as required.
This position will have a significant role in supporting the development and optimization of electronic Quality Systems. In addition, this position will play a role in larger Information Technologies programs such as Business Intelligence, system integrations, and enterprise system enhancements.
- BS in information systems, or related field
- 5+ Years supporting business process mapping and system implementations for Technical Operations and Development Sciences functions
- Supporting business process mapping and system implementations for Technical Operations and Development Sciences functions
- Strong experience with the following systems: TrackWise, OpenText Livelink / Content Server, and / or other Enterprise Quality Management and Document Management systems
- Strong experience in project management
- Some form of Programming highly desirable, but not required
- Experience with Crystal Report development is desirable but not required
- Working understanding of GxP guidelines including 21 CFR Part 11
- Proven track record of being able to apply technologies to business functions to maximize process performance
- Experience in coordination of contract staff
- Experience in other enterprise systems such as CMMS and HP Quality Center are desirable
- Excellent verbal and written communication including strong presentation and group speaking skills
- Good organizational skills
- Must be able to work as part of a team as well as individually
- Must be able to work with limited direction and be a self-starter
- Must have a desire to learn new technologies both by instruction and self-teaching
- Must have good interpersonal skills
- Super-user understanding of MS Office applications (Word, Excel, Visio, Access, Project, Power Point)