Senior Business Systems Analyst, Quality & Compliance Systems

Canada Req #133
Friday, September 2, 2022

About OmniaBio:

OmniaBio Inc, a subsidiary of Toronto-based CCRM, is a contract development and manufacturing organization (CDMO) producing gene-modified cell therapies and viral vectors, compliant with cGMP standards.

The facility has support from the Government of Ontario, via the Invest Ontario Fund, and is the first project to be funded through the Life Sciences Strategy. The facility will be built in phases with the ultimate goal of building the largest facility of its kind in Canada (over 350,000 sq ft). OmniaBio is Canada’s first commercial-scale CDMO dedicated to cell and gene therapies.

Located on the biomanufacturing campus at McMaster Innovation Park (Hamilton, ON), OmniaBio will catalyze life sciences careers and innovation in Canada while advancing pioneering medicine with the potential to cure, not just treat, many forms of cancer, cardiovascular diseases, Parkinson’s, and diabetes, amongst others. OmniaBio will support a broad range of cell and gene therapy companies globally, enabling pivotal/Phase III and commercial-scale manufacturing.
OmniaBio will complete CCRM’s continuum of process development, clinical and commercial capabilities. CCRM is a leader in developing and commercializing regenerative medicine-based technologies, and cell and gene therapies.

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.

OmniaBio Inc. is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.


OmniaBio Inc. is committed to accessibility, diversity and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.

Other details

  • Pay Type Salary
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  • Canada