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The Manager, Quality under the direction the Director of National Infusion Pharmacy, coordinates the implementation and maintenance of the Quality Management System. The incumbent oversees the Risk Management Program, the Internal and External Auditing Program and supports business development proposals. The Manager, Quality also participates with special projects, including the development of policies, procedures and education materials across all Bayshore Specialty Pharmacies.
DUTIES AND RESPONSIBILITIES
- Understands contracts’ requirements and customers’ expectations across all BSRx departments, divisions and locations.
- Manage Policies, Procedures and SOPs and assigns them across all departments respectively.
- Ensure Policies and Procedures are maintained, updates, shared with employees, read and understood and implemented by all.
- Develop quality control processes.
- Liaise with the enterprise Quality/Risk Network as a BSRx quality representative
- Ensure compliance with all regulatory bodies (OCP, NAPRA, ISO, Health Canada and others).
- Monitor and evaluate internal production processes.
- Produce statistical reports on quality standards.
- Reports to upper management on quality standard issues and preventative action plans.
- Acts as a recall leader and manages all recall notifications from start to finish.
- Manages the quarantine process and follow up with all quarantined products to determine proper action plan.
- Act as the Privacy Officer for all BSRx facilities and where appropriate liaise with Bayshore’s Privacy Officer.
- Ensures consistent Quality practice across all BSRx facilities.
- Manages SLA sharing across departments and ensures smooth production flow.
- Work on improving production efficiency and reducing waste (Lean).
- Working with the contract holders to ensure all contract requirements are met.
- Ensure adherence to health and safety guidelines as well as legal obligations.
- Keep accurate documentation and perform statistical analysis.
- Ensure a solid survey process is in place, collect feedback, show trends and work on preventative action plan when needed.
- Manage the Risk Reporting process; meetings minutes, assignments, follow up and ensures that events are being directed to the most appropriate person and all investigations are done on time with proper root cause analysis and preventative action plan.
- Ensure that all in-house systems and procedures are updated, revised and modified to meet the needs of external certification bodies.
- Respond to customer complaints putting in containment actions, full analysis, and implementing short-term and long-term countermeasures.
- Champion a program for the implementation and sustainment of a continuous improvement culture and keep records of all initiatives implemented.
- Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and audits
- Introduce new systems and procedures where appropriate.
- Identify training needs and organize training interventions to meet quality management standards.
- Act as key contact and/or host during internal, client, third party or regulatory body audits.
- Document, track internal audits/quality assurance activities, and follow-up on action items.
- Evaluate audit findings, prepare audit reports and coordinate action plans with concerned individuals based on audit findings.
- Oversee tracking and completion of Corrective Action and Preventative Actions (CAPAs). Work with process owners to make sure that Root Cause analysis is performed properly.
- Prepare reports to communicate outcomes of audit findings/quality activities.
- Coordinate audit responses regarding deviations related to audit findings.
- Support the department in activities geared towards process and/or document improvement. This may include process optimization, assisting with the development or revision of program specific protocols and/or revision of policies and procedures.
- Manage quality assurance planning activities and execution of planned events to ensure consistency across the department.
- Conduct monitoring procedures such as data gathering, data review/analysis, and document/case file review, verification, and criteria development and make recommendations for improvement as appropriate.
- Maintain relevant level of knowledge of Health Canada GVP (Good Pharmocovigilance Practices) guidelines appropriate to the role.
- Ensure education and quality assurance programs adhere to government, company and ISO 9001-2000 standards.
- Participate in proactive Health & Safety activities while performing all duties. Notify immediate Supervisor of any Health & Safety risks or concerns. Complete Accident Reports for all direct reports who injure themselves on the job, within 24 hours of the incident.
- Maintain confidentiality of client and corporate information at all times.
- Run spot audits daily to ensure compliance.
- Manage document control and ensure its up to date and all documents are saved and readily accessible.
- Report against agreed quality metrics on a monthly basis.
- Develop, implement and manage key performance indicators (KPIs) for each area of responsibility.
- Set department objectives/KPIs and review and assess ongoing performance of direct reports.
- Work as part of the Management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimize results and improve quality of delivery, in line with quality standards requirements delivery in line with Company and Customer requirements.
- Communicate with personnel at all levels, internally and externally to the Company, in relation to Quality matters.
- Comply with the Health, Safety and Environmental Policies.
- Support and encourage team building initiatives.
- Proactively contribute to creating a good team atmosphere.
- Complete other tasks as requested.
The Manager, Quality reports directly to the Director, National Infusion Pharmacy. The Manager, Quality also liaises with the BSRx leadership, enterprise Quality/Risk and employees as appropriate.
Bachelor’s degree preferably in a health or business related field; completion of Quality Management, Risk Management or related courses is preferable. A minimum of a six sigma green belt, from a recognized quality institution. Certification as an Internal Quality Auditor is an asset.
At least 5 years of experience in organizational development, management, strategic planning and quality assurance, preferably in health care; diverse experience in development of policies and processes, reports and presentations.
Other Skills and Abilities
Strong interpersonal skills and ability to work independently and as part of a team; proven ability to build consensus and lead new initiatives; demonstrated ability and competency in Windows software, exceptional organizational skills and ability to meet deadlines; strong commitment to continual learning. Ability to communicate in French is a definite asset. Demonstrates basic clinical analysis and informatics competencies E.G. device, application and information communication technology basic skills. Demonstrates basic clinical analysis and informatics competencies E.G. device, application and information communication technology basic skills.