National Director of Quality & Regulatory Affairs

It's more than a job As part of the Contract Logistics team at Kuehne+Nagel, you will play a key role in designing, managing, and optimizing solutions that keep goods moving efficiently. Whether you’re leading a team, engineering processes, or driving projects, your work ensures that our customers’ products are stored, handled, and delivered with precision. From everyday essentials to seasonal items, what we do in Contract Logistics impacts businesses and communities around the world. At Kuehne+Nagel, your contribution goes far beyond the warehouse—it helps shape the flow of global trade. “If you are a current Kuehne+Nagel employee: Please ensure applications are submitted by Thursday, September 3, 2026. KN is committed to supporting internal career growth, and internal candidates will be considered first. When necessary, external candidates will be reviewed to ensure the best fit for the role and business needs.” ‎ 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 “If you require accommodation for the recruitment /interview process (including alternate formats of materials, or accessible meeting rooms or other accommodation), please let us know and we will work with you to meet your needs." 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. “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.” Who we are Logistics shapes everyday life - from the goods we consume to the healthcare we rely on. At Kuehne+Nagel, your work goes beyond logistics; it enables both ordinary and special moments in the lives of people around the world. As a global leader with a strong heritage and a vision to move the world forward, we offer a safe, stable environment where your career can make a real difference. Whether we help deliver life-saving medicines, develop sustainable transportation solutions or support our local communities, your career will contribute to more than you can imagine. We kindly advise that placement agencies refrain from submitting unsolicited profiles. Any submissions of candidates without prior signed agreement will be considered our property and no fees will be paid.

Lead the national quality and regulatory affairs strategy for healthcare contract logistics, ensuring compliance with GMP, GDP, and Health Canada regulations. Partner with operations and customers to optimize quality systems, manage audits, and drive continuous improvement across multiple sites.

Requires over 15 years of experience in Quality Assurance or Regulatory Affairs within pharma or medical devices, including 6+ years of multi-site leadership. Must have deep knowledge of Health Canada regulations and experience in 3PL distribution environments.

• Health benefits • Dental benefits • Retirement savings plan • Tuition reimbursement

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Quality Management System
• Regulatory Compliance
• GMP
• GDP
• ISO Standards
• Lean Six Sigma
• CAPA Management
• Change Control
• Vendor Qualification
• Cold Chain Management
• Computer System Validation
• Risk-Based Decision Making
• Audit Leadership
• Stakeholder Management
• Strategic Planning
• KPI Reporting

• Logistics
• Management & Leadership
• Healthcare
• Transportation
• Security & Safety

Expérience minimale

15+ ans

Postuler avant le

24 sept. 2026

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Director