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BD (Becton, Dickinson and Company) Senior Manager, Quality Systems - Document and Data Management in Franklin Lakes, New Jersey

Job Description SummaryThe Senior Manager, Quality Systems - Document and Data Management, is directly responsible for managing the development, implementation, and improvement of the BD Medication Delivery Solutions (MDS) Franklin Lakes Unit Document and Data Management Systems. This position ensures that various Document and Data Management processes such as Document Control, Quality Records Management, and Change Control are effectively implemented and comply with FDA Quality System Regulations, ISO 13485, EU MDD/MDR, other MDSAP country regulations as well as any other applicable regulations/standards for MDS products. This position is responsible for day to day management of the MDS Document Management team function; collaborates with cross functional partners such as R&D, PMO, Master Data, Platform teams, RA, Medical Affairs to ensure that the document and design history file structure is aligned with their needs and applicable regulations.

The Senior Manager, Quality Systems - Document and Data Management, provides support to the management of external regulatory/ISO/NB inspections/audits at the BD MDS Franklin Lakes location as well as inspections/audits at the MDS manufacturing sites. This position represents MDS Business in the BD initiatives aimed at harmonizing and improving the document and data management processes and ensures these processes are effectively implemented at MDS sites.

The Senior Manager, Quality Systems - Document and Data Management, reports to the Sr. Director, Quality Systems.

Job Description

The summary below provides key responsibilities for the Senior Manager, Quality Systems - Document and Data Management:

  • Manages the document and data management processes for the MDS Franklin Lakes site. These include Document Control, Quality Records Management, Change Control.

  • Collaborates with cross functional partners such as Quality Engineering, R&D, Master Data, Regulatory Affairs, Post Market Quality, Operations, Medical, Marketing to understand their needs and incorporate them in the document and data management processes.

  • Collaborates with R&D to develop and implement a strategy for managing Design History File. Ensures the relevant records are available to the design centers, legal manufacturers and manufacturing sites, as appropriate.

  • Participates in the management of external regulatory inspections and audits at the MDS Franklin Lakes site. Supports design centers, legal manufacturers and manufacturing sites during their external regulatory inspections.

  • Represents MDS Business in BD initiatives aimed at harmonizing and improving Document and Data Management processes and drives their implementation at MDS sites.

  • Manages and coordinates the Document and Data Management staff. Carries out Human Resource management responsibilities such as hires, job assignments, coaching, termination recommendations, succession planning, promotions, salary actions, and processes performance reviews on time.

Must have’s:

BS in a related scientific or engineering discipline.

At least 6 years of related supervision experience in Quality, Regulatory, or Operations of a Medical Device firm.

Knowledge of SAP change management / PLM and master data concepts:

· General SAP use

· SAP master data objects (material master, bill of material, task lists, etc.) and their relationships

· SAP engineering change management

· SAP Business Intelligence or Business Warehouse Advanced PC skills in MS Office, incl. advanced data analysis in MS Excel and MS Access, and other reporting and productivity tools

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.

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Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

Work ShiftNA (United States of America)

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

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