Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description Summary
Reporting to the MMS Vice President of Quality, the Senior Director, MMS Quality Transformation and Continuous Improvement provides leadership to the MMS Quality Improvement Program (QIP) workstreams and develops the function into a Quality continuous improvement PMO. This role significantly influences the strategy and assures alignment of tactics to achieve Division objectives for regulatory compliance into the future. Through outstanding communication; effective problem solving and active management of ambiguous situations, the Sr. Director ensures QMS process effectiveness and compliance with all relevant global regulations and customer expectations across .the MMS Division.
The MMS QIP was established to ensure successful on-time completion of all commitments to Regulatory Agencies, the effective execution and record-keeping for related recalls and to conduct deep dives to identify further areas for QMS improvement related to the CareFusion 303 legal entity for Alaris™ infusion pumps in preparation for future FDA inspections and Regulatory audits. Once established, these QMS improvements are expected to be integrated with other platform and site QMSs throughout the MMS Division over the next 2-3 years. During integration throughout the MMS Division, this position is expected to transform into a Quality Program Management Office for continuous improvement to further integrate with the BD Inspire Quality Program process improvement waves.
Reporting to the Sr. Director, MMS QIP initially will be two Workstream Directors for Regulatory Agency commitments and Field Actions and two Project Managers for scheduling, tracking and reporting. The Sr. Director, MMS Quality Transformation and Continuous Improvement will be expected to lead the third workstream for QMS optimization and inspection/audit readiness. These workstreams will be made up of broad cross-functional task leaders and process owners who will be looking to this Sr. Director, MMS Quality Transformation and Continuous Improvement for direction and guidance to improve the compliance posture and change the Quality culture of the organization.
At the incumbent’s preference, this position may either be located remotely with 20-40% travel to San Diego and other MMS sites (post-COVID-19) or may be relocated to the San Diego area.
Living the BD Values
We do what is right
We take personal responsibility
We anticipate and address the challenges of patients and customers globally
We innovate and improve continuously
We respect, collaborate, challenge and care about each other
1. Candidates MUST have:
Demonstrated broad and deep experience in all elements of medical device Quality Management Systems and deep knowledge and experience in Quality Engineering for design and manufacturing; experience in multiple compliant QMSs is preferred.
Demonstrated significant and broad leadership experience in Quality turnaround situations, such as Warning Letters or Consent Decrees and multiple turaround experience is preferred.
Demonstrated knowledge of “what good looks like” for effective and compliant practices, procedures and records in all areas of the QMS.
Demonstrated ability to teach, coach and guide task leaders and process owners to make the improvements required to achieve zero findings/observations in future inspections/audits.
Demonstrated success in changing an organization’s Quality culture.
2. Lead or influence quality networks, businesses, associates and capital resources toward the effective promotion and alignment of organizational goals to the company’s mission and vision.
3. Proactively identify and work through obstacles that may hinder the organization from focusing on and delivering their objectives.
4. Actively pursue up-to-date industry knowledge and implement benchmark and best-practice activities that maintain exceptionally high levels of product quality and compliance.
5. Demonstrates strong big-picture thinking; effectively integrates and balances long-term opportunities and challenges, with day-to-day activities
6. Ensure the Quality organization is designed and resourced to fulfill its obligations and to comply with applicable regulations and procedures.
7. May mentor cross functional associates
8. Focused on organization competencies and capabilities to advance the leadership bench strength of the company
9. Recognized as thought leader possessing subject matter expert knowledge for global regulations.
10. Anticipate and effectively lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions.
11. Continuously evaluate progress toward strategic goals and objectives; insuring they remain relevant.
12. Pursue and actively manage key stakeholder relationships that support the broader strategy.
13. Command/direct significant customer issues; developing quality and compliance minded solutions that uphold the reputation of the company and its standards. 14. Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors.
Key Responsibilities for this Role:
Provide BD executive management with assessments of assigned Quality Improvement Program (QIP) Workstream action. Develop strategies to correct and prevent these issues.
Work with Project Managers and Workstream Directors to develop plans to implement Quality Improvement Program (QIP) Workstream activities
Work with task leaders to implement Workstream objectives
Assist teams with establishing future state of enhanced compliance and coach teams on achieving future state
Champion continuous process / product improvement
Policy and Strategy
Establishes strategy and direction.
Ensures effective implementation for the assigned quality function in alignment with strategic plans established with top management and executive leadership. Contributes to business strategies and plans.
Sphere of Influence
Interacts both internally and externally with executive-level management, requiring negotiation of extremely critical matters. Influences policy making (e.g. via the EQLT). Regularly interacts with various stakeholders on important matters concerning cross-functional, cross-business areas and/or external customers. Understands and works to improve effectiveness of the BD matrix.
Broad function-wide objectives are established under the general direction of senior management. Consideration includes: time in the role, expanded responsibilities, size of the business, multi-site responsibilities, and involvement in global initiatives.
Directs and controls the activities of one or more functional areas through designated managers who have overall responsibility for the successful operation of those assigned areas.
Advances the global leadership bench strength of the company.
Impact of Decisions
Decisions and recommendations have a significant long-term impact on the unit and affect the financial, associate, or public relations position of BD.
Directs and controls the activities of one or more functional areas through designated Task Leaders and associated teams who have overall responsibility for the successful operation of those assigned areas.
EDUCATION AND EXPERIENCE REQUIREMENTS
Bachelor’s Degree in science, engineering or other relevant discipline; Engineering degrees are preferred and a Master’s in Engineering is a plus.
Minimum of fifteen years of relevant experience across all areas of the QMS.
One or more ASQ Certifications are preferred and Certifications in Quality Engineering and Six Sigma Master Black Belt are a plus.
Must possess the following traits and skills:
Ability to make timely critical decisions regarding product quality and/or quality system compliance
Excellent leadership, communication, organization and project management skills
Ability to communicate to MMS leadership team regarding quality issues and quality decisions
Ability to effectively lead teams and influence business/platform leaders
Ability to evolve a quality system towards higher levels of performance, efficiency, and compliance
Strong knowledge of worldwide medical device regulations
Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA CA - San Diego TC Bldg C&D
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
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To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
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