Quality Management Business Analyst

United Kingdom, Hertfordshire, Welwyn
Canada, Ontario, Mississauga

de fr es ru tr it pt zh ja

As a Pharma Development Informatics Business Analyst (BA) you will be responsible for scoping, planning and supporting the successful implementation of technology  solutions by providing business analysis, best practice research, detailed requirements and user stories definition and user acceptance facilitation. In addition you will  be required to work closely with  Business Users,  Product Owners, Product Managers, IT Business Partners and IT Architects  to develop a conceptual architecture for the solutions.

Your will help drive successful completion of major projects/programs across portfolios. Your impact may be within or across multiple portfolios and you will champion accountability by example.

Your initial assignment will be in the areas of drug development quality management related processes.

You will work on: 

  • Identifying and documenting business processes and improvements for QMS domain in a GxP environment.

  • Identify opportunities for improvement and efficiencies gained by successfully adopting new QMS solutions i.e. Veeva.

  • Create high quality user and functional requirements and user stories

  • Work closely with the Product Owner to analyze requirements to determine priority and business value

  • Create and maintain prioritized backlog items for development

  • Facilitate meetings, document meeting notes and distribute meeting notes to invitees 

  • Facilitate interviews, site visits and workshop sessions with business users one-to-one and in groups as needed 

  • Create required regulatory and SDLC documentation 

  • Create ASIS and to-be process maps and narratives 

  • Create requirements traceability matrices 

  • Provide estimates for workstream activities, including dependencies, to the Project Manager 

  • Identify, manage and resolve risks and issues related to the workstream

  • Contribute to all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training 

  • Work with project teams to ensure compliance with regulatory requirements such as FDA, CAPA, CLIA, GxP,HL7 as well as internal policies and processes 

  • Create and deliver training materials to end users Collect and monitor progress on project activities from resources 

The ideal candidate:

  • Brings a scientific background (e.g. biology, medicine, biochemistry, pharmacy, or data science). Knowledge of clinical studies

  • Has deep business process domain knowledge and stays abreast of technology innovation in their domains

  • Prior GxP and QMS related experience with CAPA, Change Control, Investigation Management, Document Management, Validation and Training

  • Extensive years in life sciences/pharma

  • Has excellent communication and influencing skills. 

  • Has experience facilitating meetings and workshops

  • Always demonstrates leadership in his/her assignments.

  • Applies advanced theoretical knowledge and establishes new principles and concepts to independently address strategic business technology problems.

  • Exhibits intellectual curiosity and integrity and has strong passion to bring value-adding technology to the business.

  • Has experience working in agile environments and exhibits a mindset in the approach to:

    • Enable a diverse group of partners to speak with a single voice

    • Ensure the right information is available to the development team in the right level of detail at the right time so that the product can be developed.

  • Up-to-date knowledge of data technology trends and utilities in general, in particular for quality drug development. 

  • Experienced with informatics systems, relational databases, SQL, and data visualization tools.