Senior Business Systems Analyst, ERP/MRP Systems

About OmniaBio:

OmniaBio Inc. is a subsidiary of Toronto-based CCRM (ccrm.ca), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial-scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is expected to be the largest facility of its kind in Canada.

Based at McMaster Innovation Park in Hamilton, Ontario, OmniaBio will anchor a biomanufacturing centre of excellence and open in three phases between 2024 and 2026. OmniaBio has built a substantial team and continues to grow to prepare for this expansion. Benefitting from CCRM’s existing expertise and business practices, OmniaBio currently has established process and analytical development teams and contract manufacturing capabilities. OmniaBio is built upon leadership in induced pluripotent stem cells (iPSCs), immunotherapy and lentiviral vectors (LVVs). The vision is to provide focused support for clients with late clinical-stage manufacturing and commercial supply needs, in addition to early-stage development and first in-human clinical trial material services. Please visit us at omniabio.comto learn more.

Role Summary:

The Senior Business Systems Analyst, ERP/MRP Systems reports to the Project Manager, ERP/MRP Systems. This position requires analytical and critical thinking skills and the ability to understand business processes and objectives. The role of the ERP/MRP Senior Business Systems Analyst is to elicit, analyze, specify and validate the business needs of project stakeholders in finance, accounting, procurement, manufacturing and others to assist with the ERP system selection, implementation and ongoing support and improvements. This includes interviewing stakeholders, and gathering and compiling user requirements, to convey to the technical teams throughout the software implementation life cycle. The Senior ERP Analyst will also apply proven communication, analytical and problem-solving skills to support the development process, and to ensure that project deliverables meet specifications. The Senior ERP Analyst will play a pivotal role in ensuring the IT team understands the business requirements. As well to ensure support, improvements and optimization of systems enhance business processes optimal performance.

Responsibilities:

   Strategy and Planning

• Collaborate with project managers and project sponsors to determine project scope and vision.
• Identify project stakeholders and establish user classes, as well as their characteristics.
• Conduct interviews to gather user requirements through workshops, questionnaires, surveys, site visits, workflow storyboards, use cases, scenarios, and other methods.
• Identify and establish the scope and parameters of requirements analysis on a project-by-project basis to define impact, outcome criteria and metrics.
• Work with stakeholders and the project team to prioritize requirements.
• Research, review and analyze the effectiveness and efficiency of existing data collection processes and develop strategies for enhancing or further leveraging these processes.

Acquisition and Deployment

• Assist in conducting research on software and hardware products to meet agreed-upon requirements and to support the selection efforts. 
• Participate in the quality analysis of selected solutions to ensure that the features and functionalities have been enabled and optimized. 
• Participate in the creation of operational procedures and documentation for software solutions that the organization may opt to use.

Operational Management

• Analyze and verify requirements for completeness, consistency, comprehensibility, feasibility and conformity to standards.
• Develop and utilize standard templates to write requirements specifications accurately and concisely.
• Translate conceptual user requirements into functional requirements in a clear manner that is comprehensible to ERP consultants, developers and the project team.
• Assist with developing prototypes of interfaces and attributes based on the user requirements.
• Create process models, specifications, diagrams and charts to provide direction to developers and/or the project team.
• Develop and conduct peer reviews of the business requirements to ensure that requirement specifications are correctly interpreted.
• Assist with the interpretation of user requirements into feasible options, align with ERP consultants and support personnel, and communicate recommendations back to the business stakeholders.
• Manage and track the status of requirements throughout the project or enhancement lifecycle; enforce and redefine as necessary.
• Communicate changes, enhancements and modifications of business requirements – verbally or through written documentation – to project managers, sponsors, ERP consultants, vendors and other stakeholders so that issues and solutions are understood.
• Analyze day-to-day functions and processes of the system to ensure performance within predetermined guidelines, limits and specifications.
• Identify and resolve application issues to maintain services, enhance capabilities and prevent system outages.
• Prepare and deliver reports, recommendations or alternatives that address existing and potential trouble areas in ERP applications across the organization.

Requirements:

• 10+ years’ experience with business and technical requirements analysis, elicitation, modeling, verification and methodology development. 
• Previous experience in the gathering of requirements for the selection, implementation, and on-going support of ERP and MRP systems.
• Demonstrated knowledge of the core ERP business processes, including procurement, finance, manufacturing and warehousing (material management) processes and operations is essential. 
• Experience in supporting multiple ERP systems, preferably in a biotechnology or life sciences environment.
• Ability to create systematic and consistent requirements specifications in both technical and user-friendly language. 
• Experience in business process mapping tools and techniques.
• Understanding of business systems analysis, application development and software development life cycle concepts. 
• Working exposure to the design, development and implementation of software solutions. 
• Ability to work positively in a matrixed environment with several business units, IT teams and vendor resources.
• Strong understanding of Good Manufacturing Practices (GMP) and Good Automated Manufacturing Practices (GAMP) standards including the computer system validation process for GxP systems is preferred.
• Experience in IT and Quality change control processes.
• University degree in computer science, science or business.

Desired Characteristics:

• Working experience with contract development and manufacturing organizations (CDMOs) is an asset
• CBAP Certification or equivalent would be an asset
• Ability to exercise independent judgment and act.
• Excellent analytical and creative problem-solving skills.
• Excellent listening, interpersonal, written and oral communication skills.
• Logical and efficient, with keen attention to detail.
• Highly self-motivated and independent.
• Ability to effectively prioritize and execute tasks while under pressure.
• Strong customer service orientation.
• Experience working in a team-oriented, collaborative environment.
• Possesses a team-oriented approach to meeting goals and objectives.
• Demonstrated ability to complete tasks successfully without supervision and to work in a deadline-driven and dynamic environment.
• Strong organizational skills.
• Demonstrated leadership capabilities and ability to work as a team player in a highly collaborative organization