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About the role
Key responsibilities & impact- Provide regional quality support for commercial, transportation, and customer service operations across North America.
- Support development, implementation, and maintenance of processes and controls for commercial and transportation operations.
- Lead regional improvement strategies and optimize quality service models.
- Help define Regional Quality Objectives, monitor progress, and present quality performance through metrics, scorecards, and quality reviews.
- Ensure compliant execution of transportation lane-mapping studies, transportation mode qualifications, and temperature-control and monitoring systems.
- Provide supplier quality support for transportation and temperature-control suppliers.
- Lead reviews of transportation-related temperature excursions and assess potential product-quality impact.
- Partner with manufacturing quality, distribution center quality, Deliver, customer service, and other business teams to resolve quality issues and improve processes.
- Lead or participate in product and process risk assessments.
- Ensure non-conformances and CAPAs are initiated, assigned, investigated, documented, completed, and checked for effective resolution.
- Implement projects to reduce nonconformances, improve cycle times, increase efficiency, and support cost-improvement objectives.
- Educate business partners on quality-system requirements and regulatory compliance.
- Represent Quality in cross-functional projects, governance meetings, process-improvement work, and innovation initiatives.
- Support audit and inspection readiness and participate in audits or regulatory inspections.
- Address time-sensitive quality issues and support colleague development through coaching and knowledge sharing.
- May oversee 0 to 1 contractor or other direct/indirect resource.
Requirements
What you’ll need- Bachelor's degree.
- 6-8 years of relevant business experience in an FDA- or Health Canada-regulated industry.
- Experience in Quality Assurance, Quality Systems, Supply Chain, or Transportation Operations.
- Working knowledge of cGMP requirements applicable to one or more regulated product categories, including cosmetics, over-the-counter products, OTC monograph products, or medical devices.
- Experience leading complex or strategic projects.
- Experience with investigations, root-cause analysis, CAPA, risk assessment, and quality documentation.
- Strong written, verbal, presentation, and interpersonal communication skills.
- Ability to work across organizational boundaries and influence outcomes in a matrix environment, with or without direct authority.
- Ability to analyze complex issues, set priorities, and drive work to completion.
- Up to 10% travel.
- Advanced degree in a relevant scientific, engineering, quality, or business discipline (desired).
- ASQ or project-management certification (desired).
- Experience conducting or hosting audits and regulatory inspections (desired).
- Experience with continuous-improvement methods (desired).
- Experience with transportation quality, temperature-control systems, lane-mapping studies, transportation mode qualification, or supplier quality management (desired).
- Experience using quality metrics, scorecards, and trend analysis to guide decisions and communicate performance (desired).
- Experience coaching or mentoring colleagues (desired).
Benefits
Comp & perks- Competitive Benefit Package
- Paid Company Holidays
- Paid Vacation
- Volunteer Time
- Learning & Development Opportunities
- Kenvuer Impact Networks
- Bonus (if applicable)