BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Sr. Director, WW Quality Systems in San Diego, California

Job Description Summary

The Senior Director of World Wide 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. This position will report into the World Wide VP of MMS Quality Assurance. The candidate will have an established track record of implementing and maintaining Quality Systems that are substantially compliant, efficient, and effective. This person will work with MMS entities in 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). This person will drive the Strategy, design, development, and implementation of these QMS processes. Will work closely with the PMO group to ensure that the strategy is executed as planned. In some cases, the actual term ownership of these processes will be by other MMS QA leaders. This person will also be responsible for integrating the MMS QMS into the larger BD QMS.

The Sr. Director of WW MMS QMS will act as the Management Representative and oversee internal audit program as well as management reviews, Training and CAPA management. Accountable for KDGs and metrics related to ongoing quality performance will be analyzed and escalated to Sr. leaders.

Job Description

The Sr. Director of Quality Systems will help drive the MMS Infusion business strategy as follows:

  • Revenue Growth – this position is responsible for the effectiveness of the MMS QMS. If the QMS effectiveness is not maintained at a high level then ship holds, recalls, and regulatory actions may result which can have a significant negative effect on the customer experience and on revenue growth.

  • Operational Effectiveness— this position is responsible for ensuring the MMS QMS is efficient and does not become an inhibitor to operational effectiveness

  • Innovation—the MMS product development process is done under the MMS QMS. This QMS must be efficient and effective in order to develop new products in a timely fashion and ensure that they are of the quality the customer expects.

  • Requirements The candidate must have hands on experience designing, implementing, and maintaining Quality System processes for medical devices. These processes include CAPA, Change Control, Post Market Surveillance, Internal Audit, Process Controls, and Design Controls. This person should have a solid understand of what a good QMS process looks like based on experience across multiple companies or business units. The candidate must be able to demonstrate they can develop a QMS that is both substantially compliance and efficient.The candidate must have an expert knowledge of applicable regulations and standards including FDA QSR, ISO-13485, EU MDD, and EU MDR.The candidate will have direct reports. They will also be responsible for driving the MMS QMS upgrade project that seeks to achieve compliance with MDR and also seeks to drive QMS efficiency and effectiveness. As a driver of this QMS upgrade project this candidate will direct QMS process designers and process owners.Ideally the candidate would have over 10 years’ 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.The candidate must we 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. This person must have 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.

For many 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, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

DirectEmployers