Sr. Director Quality Systems

Job Description BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and 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. Role Overview This role will lead all aspects of the Medication Management Solutions (MMS) entities, including but not limited to San Diego and Tijuana, to seek quality system harmonization across the entities and to drive these systems to meet changing regulatory demands (e.g., MDR, QMSR). Drive the design, development, and implementation of these QMS processes with corporate and business objectives. In some cases, the actual ownership of these processes will be by other MMS QA leaders. Complete the integration of the MMS QMS into the larger BD QMS and Inspire Quality (IQ) initiatives. Drive the MMS QMS upgrade project that seeks to achieve compliance with EUMDR and seeks to drive QMS efficiency and effectiveness. Act as the point person for internal and external audits and inspections, with organizational skills and strong communication to regulatory agencies. Coordinate external MMS communications with regulators to establish consistency and trust. Responsibilities Compliance – Ensure compliance with global regulatory standards for medical devices and non-medical devices across various physical locations and entities. Effective and efficient Quality Management – Ensures the MMS QMS is efficient, compliant and simplified to promote the best quality practices. Leadership – Leads or influences quality networks, businesses, associates and capital resources toward the effective promotion and alignment of organizational goals to the company’s mission and vision. Demonstrates strong big-picture thinking; effectively integrates and balances long-term opportunities and challenges with day-to-day activities. Innovation – The MMS product development process is conducted under the MMS QMS. This QMS must be streamlined to develop new products and change management practices to ensure we deliver a compliant world class customer experience. Growth – Responsible for the effectiveness of the MMS QMS. An effective QMS delivers high performing, safe products that meet and exceed customer expectations. Qualifications The candidate should have at least a BS degree in a technical field. Knowledge of industry QMS software tools (e.g., Trackwise, Agile, and Documentum) is desirable. A minimum of 12‑15 years of experience as either a leader or senior leader of QA in a site or business unit having broad responsibility for QMS processes, or as a leader responsible for a corporate-wide QMS in a highly matrixed global organization. Must be willing to travel and engage MMS entities worldwide to understand their needs and develop QMS processes that meet those needs. Excellent verbal and written communication skills and the ability to influence others within and external to the organization. Experience developing a long-term strategy for the MMS QMS and ability to fulfill this strategy. Experience managing staff, developing future quality leaders and building an organizational culture. Effectively operates in a matrix environment and influences and interacts with senior enterprise leaders and functional leaders on a regular basis. Demonstrated success leading cross-functional development, implementation, application, maintenance, and continuous improvement of Quality Systems for medical devices (including CAPA, Change Control, Document Control, Post‑Market Surveillance, Supplier Controls and Internal Audit, as applicable). Demonstrates a solid understanding of what a good QMS process looks like based on experience across multiple companies or business units in a highly matrixed global organization. Demonstrates the ability to develop a QMS that is both compliant and efficient. Expert knowledge of applicable regulations and standards including FDA QSR, ISO‑13485, EU MDD, and EU MDR. Experience leading direct reports. Certifications within Quality disciplines (i.e., CQE, CSQE, CQA, CQM) strongly preferred. Why Join Us? We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success. Location Primary Work Location: USA CA - San Diego Bldg A&B Salary Range $220,300.00 - $352,500.00 USD Annual EEO Statement Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics. #J-18808-Ljbffr BD Mexico