Becton, Dickinson and Company

Sr. Director Quality Systems

Becton, Dickinson and Company • $220K — $352K *
San Diego, CA 92154In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a technical field required; advanced degrees preferred.
  • 12-15 years of QA leadership experience in a global, matrixed organization essential.
  • Strong familiarity with QMS software tools like Trackwise and Agile is preferred.
  • Proven ability to influence and communicate effectively with diverse stakeholders and regulatory agencies.
  • Experience developing and implementing long-term QMS strategies is crucial.
  • Track record of managing and mentoring staff in a quality-centric environment required.
  • Expert understanding of FDA QSR, ISO-13485, EU MDD, and EU MDR regulations is necessary.

Responsibilities

  • Drive MMS QMS strategy to ensure compliance with global regulatory standards for medical devices.
  • Ensure the MMS QMS is efficient and compliant to promote optimal quality practices.
  • Lead quality networks and influence alignment with the organization's mission and goals.
  • Streamline QMS processes to support product development and enhance customer experience.
  • Ensure effectiveness of the MMS QMS to deliver high-performing, safe products.
  • Act as point of contact for internal and external audits and inspections, ensuring regulatory communication is consistent.

Benefits

  • Opportunity to lead and drive strategic quality initiatives across multiple global entities.
  • Role offers significant influence within a highly matrixed organization.
  • Engagement in a robust product development process underpinned by strong QMS systems.
  • Potential for professional growth through leadership development and mentoring opportunities.
Full Job Description
Job Description

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 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 

Salary Range Information

$220,300.00 - $352,500.00 USD Annual

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

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At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

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Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

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Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

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BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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