Staff Quality Specialist

Responsibilities

• Support the development, implementation, and maintenance of processes and controls for commercial and transportation operations in accordance with company policies, procedures, global quality systems, applicable regulations, and cGMPs.
• Lead regional improvement strategies, including the development, implementation, and optimization of quality service models.
• Support Regional Quality Objectives by helping define measures, monitoring progress, and presenting quality performance through metrics, scorecards, and quality reviews with Deliver Operations.
• Ensure compliant regional execution of transportation lane-mapping studies, transportation mode qualifications, and transportation temperature-control and monitoring systems.
• Provide supplier quality support for transportation and temperature-control suppliers in accordance with applicable purchasing-control procedures.
• Lead reviews of transportation-related temperature excursions and assess potential product-quality impact.
• Partner with Internal and External 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 related to commercial and transportation operations are initiated, assigned, investigated, documented, completed, and checked for effective resolution.
• Implement projects that reduce nonconformances, improve cycle times, increase efficiency, and support cost-improvement objectives without compromising quality or compliance.
• Educate business partners on quality-system requirements and their effect on product quality 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 as assigned.
• Balance competing priorities, address time-sensitive quality issues, and support the development of colleagues through coaching and knowledge sharing.