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Manager, Quality Systems, Distribution Operations

Company: Becton, Dickinson and Company
Location: Redlands
Posted on: July 30, 2022

Job Description:

Job Description SummaryOperates under direct line supervision to the Assoc. Director, Quality Management, US Distribution Centers. Primary responsibilities include assuring the DC maintains a robust, effective Quality Management System that complies with applicable regulations and BD procedures. The role will provide Quality oversight and also assure that the local organization and resources adequately support BD's requirements and priorities in order to create customer value addressing elements critical to Business success.Oversee and assure the DC maintains a robust, standardized and effective Quality 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.Job DescriptionBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.Living the BD ValuesWe do what is rightWe take personal responsibilityWe anticipate and address the challenges of patients and customers globallyWe innovate and improve continuouslyWe respect, collaborate, challenge and care about each otherPRIMARY RESPONSIBILITIESQuality Management: Distribution center experienceManaged at least 6 peopleAudit experienceISO 13485 experienceResponsible 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.Partner with and/or review Operation's investigations and effective corrective actions to drive solutions that reduce damage 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.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.MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:Bachelor's DegreeFive to seven years' Quality experience in Medical Device and/or Pharmaceutical regulated industry. Experience in Supply Chain and/or Distribution Center Operations preferredKnowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820ISO 13485 and 21 CFR 820 Lead Auditor certified preferredExcellent oral and written communication skillsComputer skills (Excel, Word, Power Point, etc.)Experience with direct reportsExperience with operations and inventory management and interacting with leadership from those functions.SUPERVISIONDirect Workload Staff Engineer, QualityQuality System SpecialistSpecialist 3, Quality AssuranceFor certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates.To learn more about BD visit, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.PDN#LI-OPS Primary Work LocationUSA CA - Redlands Distribution CtrAdditional LocationsWork Shift

Keywords: Becton, Dickinson and Company, Redlands , Manager, Quality Systems, Distribution Operations, Professions , Redlands, California

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