Sr. Director Quality Systems

Usa Ca - San Diego Bldg A&bsenior

OtherDirector

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Quick Summary

Requirements Summary

The candidate should have at least a BS degree in a technical field. Knowledge of industry QMS software tools (e.g., Trackwise, Agile,

Technical Tools

OtherDirector

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

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Requirements

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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

$220,300.00 - $352,500.00 USD Annual

What We Offer

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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.