Job Description Summary

Operates under direct line supervision to the Sr Manager, Quality, US Distribution Management. Primary responsibilities include assuring the DC maintains a robust, effective Quality Management System that complies with applicable regulations, laws and BD procedures. The role will provide Quality oversight at BD’s large capacity DCs with greater levels of complexity due to the number of business units served, additional services provided such as returns, reboxing, etc. The Sr. Manager, Quality, Distribution Operations assures the local organization and resources adequately support BD’s requirements and priorities in order to create customer value addressing elements critical to Business success.

Job Description

Operates under direct line supervision to the Sr Manager, Quality, US Distribution Management.  Primary responsibilities include assuring the DC maintains a robust, effective Quality Management System that complies with applicable regulations, laws and BD procedures.  The role will provide Quality oversight at BD’s large capacity DCs with greater levels of complexity due to the number of business units served, additional services provided such as returns, reboxing, etc.  The Sr. Manager, Quality, Distribution Operations assures the local organization and resources adequately support BD’s requirements and priorities in order to create customer value addressing elements critical to Business success.

POSITION OVERVIEW

Oversee and assure the DC maintains a robust, standardized and effective Quality Management System which complies with applicable regulatory requirements and Quality Agreements established with business units served. Ensure the DCs’ processes, organization, procedures, and activities are adequate to effectively meet the needs of the US Supply Chain and conform to all applicable regulatory requirements and regional standards. 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. Determine, establish and implement training and development programs that enhance the overall skills of the Quality organization and optimize knowledge, expertise, practical application, performance and succession planning. Ensure effective implementation and execution of Quality processes conducted under the Quality Systems to accomplish expected requirements and performance. Utilize metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business. Lead and/or participate in regularly scheduled Quality Leadership calls to ensure timely implementation of agreed upon actions and facilitate cross site exchange of performance and synergistic activities. 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. Maximize the benefits for the overall system to drive Business, Supply Chain performance and customer satisfaction.

PRIMARY RESPONSIBILITIES

• Responsible for the development, maintenance and execution of the DC Quality Management System in compliance to ISO 13485, 21 CFR 820 (QSR), BD Corporate Policies and Procedures, Regional Quality Standards, and other applicable regulations.
• 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.
• CPR-036 Subject Matter Expert facilitating training to DC personnel and direction where correct identification of damaged product is unclear and/or escalation to the business is required for final disposition. 
• 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 SAP ECC6.0 non-conformance process (Quality Notification/QN), 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 and timelines. 
• Facilitate the escalation process with businesses where disposition of inventory identified for scrapping is not meeting established timelines.
• Facilitate the escalation process with the Social Investing group as applicable where disposition of inventory identified for donation to charitable organizations is not meeting established timelines.
• SAP ECC6.0 Subject Matter Expert for DC Quality processes facilitating training, coaching and direction. 
• Ensures compliance to standardized processes.
• Designated business unit Quality representative for facilitation and supervision of remediation/rework activities with DC personnel. 
• Provides on-site training on behalf of the business units on rework protocols when required.
• 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 BD 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.  Manage the Internal Quality System Audit program and any local internal auditors.
• 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.

• BS Degree in Quality Engineering preferred, or related discipline.
• Five to seven years’ Quality experience in Medical Device and/or Pharmaceutical regulated industry. 
• Experience in Supply Chain and/or Distribution Center Operations preferred
• Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820
• ISO 13485 and 21 CFR 820 Lead Auditor certified preferred
• Excellent oral and written communication skills
• Computer skills (Excel, Word, Power Point, etc.)  

Primary Work Location

USA IN - Plainfield

Additional Locations

Work Shift