Manager, System Validations
Dynacare•Brampton, ON
•Hybrid
About The Position
The Manager, System Validations will lead the System Validation Analysts and is responsible to guard clinical quality by developing, recommending, implementing, training on and monitoring and improving the Dynacare policies and procedures for system validations. The Manager, System Validations is also responsible for integrating best national practices and policies and to act as the product owner for the Dynacare Quality Management Systems.
Requirements
- BSc or other relevant post-secondary education
- Clinical/medical education or training
- Information technology education or experience
- Management or leadership training required
- Knowledge of internal Quality Assurance programs, audits and protocols
- Knowledge of Laboratory Accreditation requirements and processes
- Knowledge of IT and laboratory operations, processes and continuous improvement methodologies
- 5 years previous related experience required to perform job
- Capability of understanding the scientific and technical functions of the Scientific and Operational departments
- Project governance and project management with respect to the quality department
- Proficiency with IT systems such as the Laboratory Information System (LIS) to access and analyze key data and create various reports
- Power user of analytics tools (including Word, Excel, Power Point, Outlook)
- Proficient understanding of various software systems and system architectures
- Strong people leadership skills to engage, inspire and develop employees
- Capability to apply interpersonal skills and techniques to interact effectively with others at all levels within Dynacare
- Demonstrated ability to communicate in a concise, easily understood manner, both written and orally
- Ability to think strategically and make decisions that will benefit all areas of the enterprise
- Strong decision-making ability to effectively manage constraints and competing priorities; ability to multi-task and demonstrated success in both
- Capability to apply great attention to detail, and ability to effectively manage time and competing priorities
Responsibilities
- Lead system validation quality assurance team members; team effectiveness, roles and responsibilities, goals setting and performance management
- With the responsibility to maintain or improve clinical performance, develop, recommend, implement, monitor and improve the policies, and procedures for system validation testing across the organization
- Train and lead the Quality Assurance team in the information system validation of new assay methodologies, new products and services and new equipment utilized in the laboratory operations, specifically changes affecting AS400, Omnitech V6 and V12, Dynacare National Order Entry (DNOE), middleware (Instrument Manager, Myla, etc.), LabDirector, Bioanalyse, MedLab and result outputs (Dynacare Plus, EMRs, eResults, OLIS, etc.)
- Train on the standards for validation testing (including MFM) across the organization and ensure the competency of employees through training programs, continuing education and competency assessments
- Act as the product owner and subject matter expert on the electronic Quality Management Systems (eQMS; Document Management, Occurrence Management, Equipment Management)
- Serve as a liaison between stakeholders to ensure that adequate user and QA validation of processes/software occurs
- Support strategic, business and operational planning including budget and resource planning
- Guide the organization through regulatory, normative and Dynacare requirements to ensure processes meet their intent
- Support the external inspection processes from regulatory agencies, accreditation providers and clients
- Perform internal audits and periodic reviews of Dynacare information systems
- Representing the voice of our patients and customers, pro-actively monitor and report quality performance metrics and escalate concerns prior to their potential impact
- Support the annual quality review in collaboration with the organization
- Participate with Director, Quality Assurance to mentor and engage staff in quality programs and educate about regulatory requirements, Along with Director, Quality Assurance, nurture a culture of safety first, quality for patients and customers, service, performance innovation, adaptability, and consistency.
- Provide professional support to all external and internal clients in answering inquiries and interpreting departmental and regulatory information
Benefits
- health and wellness benefits program
- RRSP match benefits
- employee stock purchase program
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What This Job Offers
Job Type
Full-time
Career Level
Manager
