Global VP, Quality & Compliance Strategy for Medical Devices

Worldwide Vice President, Quality Management (QVP) – Advance Patient Monitoring Job Summary The Worldwide Vice President, Quality Management (QVP) is responsible for shaping and advancing the Advance Patient Monitoring’s (APM) strategic quality agenda while ensuring regulatory compliance throughout the product lifecycle. The WW VP, QM APM is the designated Management Representative for the APM business. As a member of both the APM Leadership Team and the Quality Leadership Team (QLT), the QVP partners closely with business, segment, and corporate leaders to ensure the Quality strategy supports business priorities, accelerates innovation, and drives achievement of key quality and compliance objectives. Operating across site, business unit, and central teams, the QVP establishes and aligns Quality strategies, policies, processes, and performance systems that support design centers, manufacturing sites, and the supplier base delivering products and solutions to APM customers. The QVP is responsible and accountable for all aspects of innovation acceleration, product quality and compliance throughout the product lifecycle including post market. The individual in this role is responsible for managing and facilitating the Management Review Process, including the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures, and that any improvements or changes in the quality system are implemented and documented. Job Responsibilities Provide strategic leadership for the APM Quality organization in support of business objectives, ensuring alignment with corporate and business unit Quality strategies while enabling innovation and operational excellence. Serve as an active member of the APM Leadership Team and the Quality Leadership Team (QLT), contributing to enterprise quality strategy and decision‑making across regions and functions. Partner across business unit functions to design, deploy, and continuously improve innovative, effective, and compliant Quality processes, systems, and tools that accelerate new‑product commercialization and reduce time to market. Lead the evolution of Quality functional work systems, methodologies, and capabilities, focusing on operational efficiency, scalability, and sustained competitive advantage. Drive Quality Excellence through end‑to‑end BD Excellence processes by developing the organizational capabilities, systems, and governance required to deliver consistent outcomes across engineering, manufacturing, and distribution. Lead the deployment of BD Excellence Lean principles, fostering a culture of daily management, continuous improvement, and Lean‑driven quality performance. Champion a prevention‑focused Quality culture by “bringing quality into daily view,” reinforcing accountability, and branding Quality as an enabler of innovation, productivity, and operational excellence. Ensure the Quality Management System effectively incorporates existing and emerging regulatory and customer requirements, translating regulatory expectations into practical, sustainable processes that are consistently implemented and maintained. Lead and oversee field action decision‑making, including risk assessment, regulatory impact evaluation, and cross‑functional alignment, to ensure timely, compliant, and effective resolution of product quality issues in partnership with Regulatory Affairs and Medical Affairs. In partnership with business leaders, own resourcing and execution of quality and compliance risk‑reduction initiatives, including robust CAPA and preventive action programs, remediation of legacy issues, and mitigation of emerging risks. Monitor, identify, and address significant quality issues through strong investigation, corrective and preventive action, and systemic improvement across products manufactured by and for the Business Unit. Report Quality System performance as the Management Representative to executive leadership through a structured and effective Management Review process, enabling data‑driven decision‑making and accountability. Act as a culture catalyst and talent multiplier by building a high‑performing, diverse, and future‑ready Quality organization through leadership development, succession planning, and continuous capability building. Foster collaboration, teamwork, and engagement across a large, global organization to strengthen end‑to‑end customer experience and business performance. Travel up to 30% and as required. Education and Experience Minimum requirements are a BS degree or equivalent in a Pharmaceutical Science, Life Science, Engineering, or Physical Science with an advanced technical degree and MBA preferred. Minimum of 15 years of experience in quality management with at least 5‑7 years of senior compliance management experience in an FDA/Competent Authority regulated environment, including managing multi‑cultural teams executing locally in different countries. Experience in the medical device industry, or a combination of medical devices, pharmaceuticals, and other related regulated environment experience. Demonstrated track record in people management including Quality Management. Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry (e.g., ISO, QMSR, GMP, GLP, GCP). Strong preference for FDA and global Pharmaceutical GMP experience. Experienced in all regulatory compliance aspects of the business: pre‑market, commercial, post‑market, and regulatory. Thorough knowledge of current quality management practices, including US FDA laws and international regulations, design controls, manufacturing and servicing. Knowledge and Skills Demonstrated ability to build and sustain strong partnerships and alliances across a complex, global business environment, fostering collaboration and alignment across regions, functions, and stakeholders. Comprehensive expertise in the application and interpretation of global regulatory standards and requirements relevant to the medical device and pharmaceutical industries, including ISO, QMSR, GMP, GLP, GCP, HIPAA, adverse event reporting, and applicable sections of 21 CFR (e.g., Parts 820, 211, 314, 600‑606, 803, and 806). Strong knowledge of pre‑market regulatory requirements, including regulatory submission and lifecycle management processes, design controls, and risk management. Proven ability to innovate and apply forward‑thinking approaches to Quality and Compliance within fast‑paced, evolving business environments. Exceptional written and verbal communication skills, with demonstrated strength in organization, project management, and influencing at senior levels. Capability to continuously assess the effectiveness of functional processes and lead progressive improvement initiatives using process excellence and continuous improvement methodologies. Strategic, “out‑of‑the‑box” thinker and change agent with the courage to challenge the status quo, lead transformation, and improve organizational performance. Leads courageously by taking personal ownership of critical issues, demonstrating sound judgment, ethical leadership, and the willingness to challenge decisions in the best interest of the organization and the customer/patient. Highly influential leader who presents compelling, well‑reasoned cases to gain stakeholder commitment and drive alignment around strategic initiatives. Applies insightful judgment by analyzing complex information, assessing and balancing risk, and making sound, timely decisions to solve business and quality challenges. Builds trust through principled leadership, transparency, and consistent demonstration of strong business ethics. Customer‑focused leader who works closely with internal and external customers to understand needs, translate requirements into effective solutions, and drive customer value. Execution‑oriented with a strong sense of urgency, effectively planning and delivering results while maintaining focus on quality and business outcomes. Committed to developing people and building strong organizational capability through talent identification, development, engagement, and succession planning. Demonstrates a strong global mindset by establishing and promoting effective Quality and Regulatory processes across multiple countries and regions, while coordinating effectively with the broader global enterprise. Prudent risk‑taker with the confidence to pursue opportunities, learn from experience, and make informed decisions that balance innovation, risk, and long‑term business sustainability. Physical Demands While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. Work Environment While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team‑oriented, fast‑paced environment. This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. Equal Employment Opportunity Statement: Becton, 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, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #J-18808-Ljbffr