Sr. Director, Quality, Dispensing

Job description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job DescriptionWe are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. The Sr. Director, Quality for the MMS-based Dispensing business will be responsible pre and post market quality activities, including leading the development, establishment and maintenance of the quality assurance and engineering programs, policies, processes, procedures and controls during design, development and transfer; ensuring that performance and quality of Dispensing products globally conform to product requirements, established standards and regulations. This role will oversee both medical device and non-medical device products in these Quality function capacities. This role will lead a team based in San Diego, CA. and other global sites conducting design and development activities. This position leads a broad Quality team and is charged with defining and completing superior Quality practices, in accordance with The BD Way and Quality Management Systems, for: Design Assurance and DFX programs, Design Quality Engineering, including sustaining design change activities, Software Quality Engineering (embedded, applications and analytics), Cybersecurity, Risk Management, Reliability Engineering, Human Factors, Test Method Development, and Validation. The Sr. Director will be a member of the Cross-functional Dispensing Platform Teams, and as such, they and team leadership will represent the interests of pre and post market Quality and Compliance within the Medication Management Solutions business unit. The Sr. Director will ensure that people and processes within the global Design & Development Quality function are capable of active management and improvement of product quality and compliance. This position reports to the VP of MMS Quality Management and is on the succession path for functional leadership. The Sr. Director, Dispensing will help drive the MMS business strategy as follows: Product Risk Management – This position is responsible for the effectiveness of MMS Quality Management System and continued reduction of risks inherent in MMS products and services, both medical device and non-medical electromechanical products based. As such, defining and maintaining a comprehensive Risk Management Program for all products is required and for Safety Assurance Cases, where required. Included are full responsibility for software and cybersecurity quality practices. This position is responsible for understanding where poor quality in design may impact our partners using field feedback data and implementing prevention and improvement processes and projects to reduce that impact. Design Controls Compliance — This position is responsible for ensuring the MMS Quality Management System elements affecting design and development are effective and efficient enabling risk control and reduction. Compliance to requirements is a must. This leader shall be proficient in the development of design process requirements and leading the organization through the necessary diligence and decisions related to conformance to those requirements throughout the product development life cycle. Design Excellence—While quality principles are well-founded in our industry, the position is responsible for identifying superior processes to enable compliance and suitable product quality levels. Critical-To-Quality initiatives will be the driving force behind focusing this team on the critical characteristics of MMS products. Automation and AI – This role should have an understanding of the latest uses of AI agentic tools and their application to Quality process, product and systems analysis and improvement. Responsibilities: This leader will be the single point of contact for Dispensing GM for all Quality and compliance matters. They will be responsible to develop strategic quality programs to oversee and foster: Design changes, New Products, product enhancements, product integrations, material changes, software creation and maintenance and represent Design Controls expert-level leadership and guidance for a dedicated team. This role is a highly matrixed and influential role having responsibility for a broad global portfolio of Dispensing products’ design and development quality practices. As such, this leader must be mature in their understanding and execution of: development of teams including succession planning organization design and deployment, cross-functional influence and negotiation, and broad organizational change management Define and influence a global quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and developing them. MMS BU-wide authority and accountability for developing, deploying, and maintaining a robust and compliant quality management system for the design, risk management, and ongoing life-cycle maintenance of BD products. Responsible for Quality Improvement Plans related to Pyxis Medical Devices Actively identify improvements to the processes within the QMS to enhance both compliance and quality. Provide expert-level understanding of design control requirements and how to deploy them in a large-scale and rapidly evolving business. Provide Design and Development leadership during FDA and Notified body site inspections. Interface with the FDA on Pre-Market Activities: Design Controls, Risk Management, Test Methods, Safety Assurance Case, Human Factors Acquire and develop excellent-level leaders and teams to support the MMS mission and actively manage bench-strength and succession planning. Represent the Quality Function in all product planning activities, such as the Platform Development Team (PDT). Conducts Quarterly Management Reviews with GM staff Identify Quality Initiatives to address field Quality issues, define prevention mechanisms for future development projects and lead cross-functional teams to complete them. Provide diligent and fact-based communication to Executive Management team, peers, and team. Assess resource needs to align the required level of quality support provided when needed with suitable competencies, including shifting resources between Platforms when appropriate. Maintain effective design-related Quality Metrics and define and complete activities to improve performance. Actively support and demonstrate the BD values in daily work. Collaborate with functional peers to articulate Strategy and Execute Transfer of manufacturing facilities and validation Post Market Quality Efficiencies in complaint handling Build service quality capabilities Integrate open acquisitions and consolidate QMS Other assignments as directed by the MMS VP of Quality. Requirements: A BS degree in a technical field (Engineering, Science, Math/Stat) At least 15 years’ of experience