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. 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. 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: Drive MMS Quality Systems strategy as follows:   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   communication s 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 1 2-15   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   Abilit