Sr. Director Quality Systems

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 Description We 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. 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. Act as the point of contact for internal and external audit actions. 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. Understands implications of decisions and communications both written and verbal. 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/business unit having broad responsibility for QMS process, 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. Knowledge of industry QMS software tools (e.g., Trackwise, Agile, and Documentum) is strongly desirable. Excellent verbal and written communication skills and have an ability to influence others within and external to the organization. Experience developing a long-term strategy for the MMS QMS and be able to fulfill this strategy. Experience managing staff, developing future quality leaders and building an organizational culture is required Effectively operates in a matrix environment and influence and interact with senior enterprise leaders and functional leaders on a regular basis is required 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. Demonstrate 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 Ability to travel and engage MMS entities worldwide to understand their needs and develop QMS processes that meet those needs Certifications within Quality disciplines (i.e. CQE, CSQE, CQA, CQM) strongly preferred Excellent verbal and written communication skills and have an ability to influence others in the organization. They must be able to develop a long-term strategy for the MMS QMS and be able to fulfill this strategy Experience managing staff, developing future quality leaders and building an organizational culture is required Ability to effectively operate in a matrix environment and influence and interact with senior enterprise leaders and functional leaders on a regular basis is required Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable and learn and improve 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. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. 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. Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understands the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. 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. 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. Primary Work Location USA CA - San Diego Bldg A&B Work Shift At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under \"Our Commitment to You\". Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. Salary Range Information $220,300.00 - $352,500.00 USD Annual #J-18808-Ljbffr RXinsider LTD.