National Contract Logistics Quality & Regulatory Affairs Are you thinking about advancing your career with one of the most successful logistics organizations worldwide? Here at Kuehne+Nagel, our Mississauga,Canada Site is looking for a new National Director of Quality & Regulatory Affairs to lead quality, regulatory compliance, and continuous improvement across our healthcare contract logistics network. How you create impact The National Contract Logistics Quality & Regulatory Affairs operates at the intersection of quality, operations, and customer experience, ensuring regulatory compliance while partnering with operations and customers to deliver efficient, compliant, and high-quality healthcare logistics solutions. You will act as a senior quality leader and trusted advisor, driving a pragmatic, risk-based approach that balances compliance with operational and customer needs, while strengthening quality culture, performance, and patient safety. Quality & Regulatory Leadership • Lead and continuously improve the Quality Management System (QMS/eQMS) across all sites • Ensure compliance with GMP, GDP, ISO standards, and Canadian licensing requirements (e.g. DEL/MDEL, Narcotics and controlled substances) • Provide compliance oversight for pharmaceuticals, medical devices, Natural Health Products, Healthcare Consumer Products, precursors, Narcotics and controlled Substances storage and distribution • Oversee CSV, facility/equipment qualification, and WMS-related compliance • Drive continuous improvement (Lean / Six Sigma) initiatives Quality Systems & Compliance • Ensure effective execution of key GMP processes such as: • CAPA and deviation management • Change control • Vendor qualification • Document and records management • Lead internal, client, and regulatory audits, including remediation • Oversee product lifecycle activities: • Product release • Complaints and recalls • Returns and destruction Validation, Cold Chain & Facility Compliance • Ensure compliance of validated facilities and storage environments • Oversee: • Temperature mapping and environmental monitoring • Cold chain processes and excursion management • Packaging qualification • Qualification/requalification of equipment and storage areas Operations & Risk-Based Decision Making • Partner with operations to embed quality into daily execution • Apply risk-based decision-making balancing compliance, cost, and service • Support customer implementations and start-ups, ensuring compliance readiness Customer & Commercial Partnership • Act as a senior quality advisor to customers • Own and govern Quality Agreements • Lead quality participation in business reviews and escalations • Support RFPs, solution design, and onboarding of new business Leadership & Governance • Lead and develop a national quality organization • Build a culture of accountability, transparency, and collaboration • Drive performance through KPIs, metrics, and executive reporting • Align quality strategy with business priorities and growth objectives What we would like you to bring • 15+ years of experience in Quality Assurance and/or Regulatory Affairs within pharma, healthcare, or medical devices • 6+ years of leadership experience managing multi-site teams and senior leaders • 5+ years of experience in regulated healthcare Third Party Logistics (3PL) distribution or wholesale warehouse environments • Strong knowledge of Health Canada regulations and GxP standards • Proven experience partnering cross-functionally with operations, customers, and commercial teams • Exposure to warehouse management systems (WMS), computer system validation (CSV), and regulated logistics operations What's in it for you At Kuehne+Nagel we strive daily to inspire, empower, and deliver not only to our customers, but also to our colleagues. We offer a dynamic global work environment with opportunities for excellent training programs and career mobility. The salary range for this position is between $120,934.00 and $151,167.00. Base wage is part of a competitive total rewards package that includes health and dental benefits, a retirement savings plan, and tuition reimbursement. Individual pay may vary from the target range and is determined by a number of factors including experience, skills, job location, internal pay equity, and other relevant business considerations. Kuehne+Nagel reviews pay ranges regularly to ensure competitive and fair pay based on industry market data. #LI-ONSITE #LI-MB1 "Artificial Intelligence (AI) tools may be used to assist in [specific process, e.g., screening applications, interview scheduling]. These tools analyze information to support decision-making, but final decisions are made by human reviewers."