Healthcare CANADA Quality Assurance & Regulatory Affairs Senior Director

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  • Burlington, ON
  • Permanent
  • Full-time
  • 21 days ago
Primary Job Posting Location:Burlington, Ontario CanadaBefore you apply to a job, select your language preference from the options available at the top right of this page.Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level.Job Description:The QA & RA Senior Director CANADA (RQA) is responsible for the oversight and implementation of the UPS Healthcare Quality Management System (QMS), UPS Healthcare Standard Operating Procedures (SOPs), processes and policies required to manage and control UPS Healthcare’s Storage, Distribution and Transportation Facilities in Canada. With oversight support the GMP DCs, GDP sites and regional third party service (GDP & GMP) providers understand and practice quality requirements, and meet UPS Healthcare’s, our client’s and regulatory agency expectations.The Quality Management System is a collective, interrelated and interactive group of defined processes and procedures that must be implemented and adhered to in order to achieve and maintain a high quality standard. These processes and procedures incorporate the current requirements of Health Canada, Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.accredited program and adherence to UPS Healthcare Quality Standards (SOPs), local laws and authority regulations, and customer requirements.This figure is responsible to attend and support inspection and visits, performed by the local Authority and certifying body.Why work for us?This is a senior regional leadership role with full ownership of Quality across GMP distribution centers, GDP sites, and third-party providers throughout Canada. You’ll lead large, high-performing QA teams, partner directly with operations, and represent UPS Healthcare with regulators, clients, and auditors. If you thrive at the intersection of strategy, compliance, and large-scale operations — this is your role.Why is this role different?True leadership scopeDirect impact on global healthcare supply chainsA chance to shape the future of healthcare logistics at scaleMain Duties and ResponsibilitiesRQA Director, is responsible for the Quality review, assessment and support of the UPS Healthcare operations and discrepancy/ issue management, Corrective and Preventive Action (CAPA) systems, change control and the management of change, performance of audits, and the management and reporting of key quality performance indicator targets (KPIs) for Regional Quality Council and issue escalation.They will also be experts on UPS Healthcare operational SOP requirements and associated documentation, deliver training/ development of staff on SOPs and processes, manage UPS Healthcare training records (internal staff and 3rd party providers), monitor quality performance, upgrade CAPA quality and timeliness, perform Global GMP (Good Manufacturing Practices) GDP (Good Distribution Practices) quality audits, manage external audits of UPS Healthcare by our clients and perform audits of 3rd Party Service providers in conjunction with the UPS Healthcare Approved Supplier (ASL) team.What you'll do:Provide Quality leadership and oversight of the Sr QA Managers, QA Managers and QA Specialists to ensure consistent implementation of and compliance to the UPS Healthcare Quality Management System at all locations in the assigned region.Communicate and maintain the UPS Healthcare quality plan to sustain the Company’s program in compliance with quality system requirements.Ensure targets are achieved through effective quality performance monitoring, measurement, and analysis and reporting. This section may include specific working hours or details of shift change.Effectively interact with Quality Associates, Quality Managers, Senior Quality Managers and Operations stakeholders to maintain quality and help introduce new quality objectives. Ensure effective controlled document review and approval.Perform internal audits, host client audits as well as perform audits of external service providers as part of the vendor selection (when required) and management process, and in doing so complete audit reports and any relevant audit follow up.Assist in the evaluation and assessment of UPS Healthcare - designated agents and/or out-sourced activities (when required)Manage discrepancies, issues, and CAPA plans, collate CAPA data, and identify and implement quality improvement initiatives and conduct effectiveness checks.Review and Approve the issues occurred in the region (when required)Identify relevant quality related training needs and deliver training where required.Identify Quality KPIs, collate KPI data and reporting. Produce KPI metrics to monitor and drive continuous improvement.Coordinate and facilitate, and lead the Regional Quality Council and contribute to the Global Quality Council.Oversee review and approve locations Validation, Calibration, and Preventative Maintenance programs to assure consistent implementation of the UPS Healthcare programs regionally in conjunction with the global validation team.Review and approve the issues occurred in the region and support other regions when it is needed.Responsibilities related to the sub-regional Quality Managers and Quality Associates:
- Guarantee the correct training of these positions.
- To do follow up to the activities done by these positions.
- To conduct at least a “1 to 1” meeting with them at least once a month.
- To define the Professional Goals annually for them.
- To support them in daily tasks and issues (not limited to the Quality Area).Service:In conjunction with the VP of Quality, manage strategic quality initiatives in order to support business growth.Maintains quality service by establishing and enforcing organisational standardsWhat you'll needBachelor’s degree or the equivalent combination of relevant education and professional experience7+ years of relevant experience, including Quality and Logistics ManagementDeep knowledge and understanding of Health Canada, GMP, GDP and ISO Compliance5+ years of pharmaceutical/biotechnology industry experienceManufacturing, Logistics and Project Management experience is a plusEnsure compliance with national and international standards and legislationEnsure timely and efficient management of records pertaining to the Quality Assurance Team.Travel as reasonably requested by the Line Manager for the performance of duties.Undertake any other reasonable duties at the request of the Line ManagerTo support daily tasks and issues as needed.To adhere to all company Policies at all times.ASQ or ISO Certification preferredTravel 25% to support facilities and Client Audits, depending on their base locationWhat you'll getBase salary plus a bonus opportunity tied to company performance, along with additional allowances. Total target compensation for this role is up to $237,000 CAD, excluding pension and benefits.UPS is a diverse and equal opportunity employer. Accommodations are available, on request, for candidates with disabilities taking part in the recruitment process. If you are selected to participate in the recruitment process, please advise if you require accommodation for a disability.

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