Sr. Quality Distribution Manager

QUALITY DISTRIBUTION MANAGER
Raleigh, NC general area (zip code 27524)
Responsible for the development, maintenance, and execution of the DC Quality Management System in compliance to ISO 13485, 21 CFR 820 (QSR), Company Corporate Policies and Procedures, Regional Quality Standards, BU Quality Agreements, and other applicable regulations.
Promote a culture of Quality across the local organization that ensures management commitment and understanding of ISO and QSR regulations as they apply to Storage, Distribution and Transportation.
Responsible for establishing and leading local site implementation of annual Quality Objectives and Key Business Drivers established for DC operations.
Responsible for managing and maintaining an effective local Quality organization, training, development programs, subject matter expertise, defining and assigning associates’ responsibilities, succession plans, establishing annual IIG’s and evaluating performance.
Serves as a Designated Representative as appropriate to ensure day to day operations meet states’ licensing requirements for medical device and/or wholesale drug distribution regulations as applicable.
Utilize metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business.
Employ and share best practices and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and best practice concepts; to introduce pro-active improvement and prevent recurrence of issues.
Partner with the businesses and provide summary input on key packaging and configuration issues in order to maintain document currency to product and customer requirements.
Effectively evaluate and provide direction to the DC with inventory that has suspected damage and is at risk of being scrapped. Manage the ERP non-conformance process, collaborate on issues to provide detailed information to source plants, vendors, or carriers to determine root cause.
Monitor for trends, escalations, and partner with sources of root causes to implement effective corrective actions that reduce non-conformances and risk in future shipments.
Oversee and monitor the scrap process to ensure compliance to procedure, timeline, and regulatory requirements (hazwaste)
Facilitate the escalation process with businesses for disposition of inventory identified as non-conforming is not meeting established timelines.
Responsible for managing and maintaining effective non-conforming product (Global Hold, Local Hold, Ship in Quarantine, Damages, etc.)
Responsible for managing and maintaining effective, efficient Returns operation that maximize value to the region and meet established performance metrics.
Responsible for managing and maintaining effective, Rebox operation that meets applicable regulatory and business unit requirements, maximizes value to business units served and meet established performance metrics.
Collaborate with Transportation on carrier related issues and driving claims to resolution where escalation is needed. Also assist Supply Chain and partner with company businesses on carrier related issues where root cause analysis and corrective actions are initiated to improve carrier performance.
Partner with Operations and Supply Chain Relations on customer related issues and driving claims to resolution where escalation is needed.
Generate monthly and quarterly metric reports for regional leadership review. Attend and participate in Regional DC Quality metric calls. Represent Quality as a member of the local DC leadership team.
Attend weekly and/or monthly site manager/process owner meetings as established.
Conduct audits as required in compliance with regulatory requirements, e.g., ISO 13485, 21 CFR 820.
Travel to support Quality Management and audit functions at other DC facilities, and support Customer visits to gain an understanding of Customer issues, determine root cause, establish and drive corrective actions and improve Customer satisfaction.
Other duties as assigned.
POSITION REQUIREMENTS
EXPERIENCE:
Minimum of 10 years’ experience within quality, supply chain, manufacturing and/or distribution.
Minimum of 3 years of experience in Distribution Center or Warehouse environment
Minimum of 5 years in general managerial or equivalent roles
Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820, preferred
Computer skills (Excel, Word, Power Point, etc.)
Experience managing >/= 6 direct reports
Experience leading audit responses
Experience with NABP and ISO audits
Experience with Boards of Pharmacy audits
Experience serving as a Designated Representative preferred
COMPETENCIES:
Process oriented, Continuous Improvement Experience
People leadership including developing, coaching, listening, collaborating, and delegating.
Organizational, analytical and process efficiency skills
Interpersonal and communication skills (written and oral)
Project leadership skills
Initiative and drive for results
EDUCATION:
Bachelor’s degree required.
Business or engineering major and/or MBA preferred
Certifications
Six Sigma Green Belt certification a plus
SUPERVISION
May have direct reporting relationship for:
Quality Management System, Non-conforming processes
Direct reports:
Quality Clerks, Quality Supervisors, Quality Engineers
SKILLS AND CERTIFICATIONS Must have a least 6 direct reports in either Quality Clerks, Quality Supervisors, Quality Engineers.Minimum of 7 years’ experience within quality, supply chain, manufacturing and/or distributionKnowledge and experience with Medical Device regulations
Sr. Quality Distribution Manager NC
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