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Job Description SummaryJob DescriptionBe part of something bigger!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. We have over 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.Our vision for the Director of Medication Management Solutions at BDThe Director of Medication Management Solutions (MMS) Quality System is responsible for ensuring that MMS entities worldwide have a robust QMS that meets/exceeds the applicable regulatory requirements.The ideal candidate has Director experience with an established track record of implementing and maintaining Quality Systems that are substantially compliant, efficient, and effective.About the role:Lead all aspects of the Medical Management Solutions entities, including but not limited to, San Diego, Tijuana, Kelberg, Vienna, and Israel to seek harmonization across the entities and to drive these systems to meet changing regulatory demands (e.g., MDR).Drive the design, development, and implementation of these QMS processes with corporate objectives. In some cases, the actual term ownership of these processes will be by other MMS QA leaders.Integrate 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. As a driver of this QMS upgrade project, direct QMS process designers and process owners.Drive MMS Quality Systems strategy as follows:Effective and efficient Quality Management — Ensures the MMS QMS is efficient and does not become an inhibitor to operational effectiveness.
Compliance – Ensure compliance with regulatory standards across different sites and entities.
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.
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 world class customer experience.
Growth - Responsible for the effectiveness of the MMS QMS. An effective QMS delivers revenue growth and margin enhancement.
About you:A seasoned quality professional, preferably with Director experience, which has demonstrated success leading cross-functional development, implementation, application, maintenance, and continuous improvement of Quality Systems for medical devices. These processes include CAPA, Change Control, Document Control, Post Market Surveillance, Internal Audit, Process Controls, and Design Controls. 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 they 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
A minimum of 10 years of experience as either a head of QA for 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 is preferred
Willing to travel and engage MMS entities worldwide to understand their needs and develop QMS processes that meet those needs
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
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
Education and experience:A minimum of 10 years of experience as either a head of QA for 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.
BS degree in a technical field
Knowledge of industry QMS software tools (e.g., Trackwise, Agile, and Documentum) is desirable.
Excellent verbal and written communication skills and have an ability to influence others in 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
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Click on Apply if this sounds like you!Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do 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. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.To learn more about BD visit https://jobs.bd.com/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&DAdditional LocationsWork ShiftBecton, 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.
Vacancy expired!