Senior Business Systems Analyst, Quality & Compliance 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, Quality & Compliance Systems reports to the Project Manager, Manufacturing & Quality Systems. This position requires analytical and critical thinking skills and the ability to understand business processes and objectives. The role of the Quality & Compliance Senior Business Systems Analyst is to elicit, analyze, specify and validate the business needs of project stakeholders in Quality and Process Development to assist with the various software and automation system selections, implementations 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 Compliance 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 Compliance 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.
• Clearly 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 project impact, outcome criteria and metrics.
• Work with stakeholders and the project team to prioritize collected 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 installation and integration of new laboratory equipment into laboratory systems such as ELN, LIMS and data collection and management systems.
• Participate in the creation of operational procedures and documentation for systems 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 consultants, developers and the project team.
• Where applicable, 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 instrument vendor engineers, system consultants and support personnel, and communicate recommendations back to the business stakeholders.
• Assist with installing, maintaining and troubleshooting of laboratory systems, and Quality and Compliance systems.
• Respond quickly to unplanned events or challenges, such as the loss of communication between instruments and laboratory data collection systems.
• Manage and track the status of requirements throughout the project or enhancement life cycle; enforce and redefine as necessary.
• Communicate changes, enhancements and modifications of business requirements – verbally or through written documentation – to project managers, sponsors, 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 quality and compliance-related applications and laboratory systems 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 Quality and Compliance Systems.
• Thorough knowledge of laboratory operations processes.
• Experience in supporting multiple laboratory software and hardware 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 and laboratory data collections solutions.
• Ability to work positively in a matrixed environment with Process Development, Quality, IT teams and vendor resources.
• Experience in IT and Quality change control processes.
• University degree in natural science, biological or chemical engineering, computer science or information technology.

Desired Characteristics:

• Working experience with contract development and manufacturing organizations (CDMOs) is an asset.
• Strong understanding of Good Manufacturing Practices (GMP) and Good Automated Manufacturing Practices (GAMP) standards, including the computer system validation process and data integrity for GxP systems, is preferred.
• ITIL process experience is an asset.
• Experience with cloud platforms is an asset.
• Demonstrated leadership capabilities.
• Ability to work independently and as a team player in a highly collaborative organization.
• Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities.
• Reacts to project adjustments and alterations promptly and efficiently.
• Flexible during times of change.
• Ability to work and communicate with team members from a broad spectrum of disciplines.
• Persuasive, encouraging and motivating.
• Ability to elicit cooperation from a wide variety of sources, including upper management, clients and other departments.
• Ability to bring projects to successful completion.
• Strong written and oral communication skills.
• Excellent conflict management skills.
• Adept at conducting research into project-related issues and products.
• Must be able to learn, understand and apply new technologies.