Job Description Summary

SUMMARY
The Sr. Director, Quality Management Systems establishes, directs and ensures that all change management, document control, training, compliance, complaint management, Pharmacovigilance Operations (adverse event reporting for pharmaceutical/medicinal products), internal audit, CAPA and management reporting activities are in compliance with the FDA Quality System Regulation, other FDA Regulations, ISO and other international regulations and BD policies and procedures that apply to devices and drug products manufactured by or for the Surgery Business Unit. Additionally, the Sr. Director, Quality Management Systems functions as a subject-matter expert for document control, change control, training, internal audits, Notified Body assessments, FDA audits, adverse event reporting, post-market surveillance, and quality systems compliance. This position is key in developing the compliance strategy for Surgery and represents Surgery in the Segment and BD Corporate initiatives.

This position is based in Warwick, RI or Vernon Hills IL, but other BD sites may be considered.

Job Description

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 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

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 will be supported to learn, grow, and become your best self. Become a maker of possible with us!

The Sr. Director, Quality Management Systems establishes, advises and ensures that all change management, document control, training, compliance, complaint management, Pharmacovigilance Operations (adverse event reporting for pharmaceutical/medicinal products), internal audit, CAPA and management reporting activities are in compliance with the FDA Quality System Regulation, other FDA Regulations, ISO and other international regulations and BD policies and procedures that apply to devices and drug products manufactured by or for the Surgery Business Unit. Additionally, the Sr. Director, Quality Management Systems functions as a subject-matter expert for document control, change control, training, internal audits, Notified Body assessments, FDA audits, adverse event reporting, post-market surveillance, and quality systems compliance. This position is key in developing the compliance strategy for Surgery and represents Surgery in the Segment and BD Corporate initiatives.

Responsibilities:

• Surgery Business Unit Functions – the following functions are traditional to Quality Management Systems leadership role:
  • Quality Systems – Directs the Surgery-wide strategy for the Quality Management System in compliance with regulations and standards around the world.  Ensures process owners are defined and coordinates continuous improvement in QMS procedures and work instructions.  Leads and supports projects to integrate Surgery and BD QMS policies, procedures and practices based on coordinated BD Integration Program plans and schedules.  Conducts required Management Reviews of key quality and performance data to ensure the quality system is adequate and effective.
  • Document Control - Directs the Surgery-wide document control activities to ensure all applicable documents are controlled and revision histories maintained.  Serves as business owner for the EDMS.
  • CAPA - Directs the Surgery-wide activities to ensure corrective and preventive action is appropriately applied to ensure products and processes address key issues and process improvements.  Reviews and approves CAPA investigations, root cause analyses, corrections, corrective actions, preventive actions and any necessary schedule extensions. Serves as business owner for the TrackWise electronic system.
  • Situation Analysis/Field Actions - Directs the activities to ensure adequate documentation for the assessment of field issues or conditions that must be considered for field action/recall decisions, escalates those decisions to the Segment level when required and ensures the implementation the field action execution when required.
  • Complaint Handling - Directs the Surgery-wide complaint activities to ensure regulatory requirements are fulfilled for complaint intake, complaint investigation, analysis of returned product to confirm complaints and determine root causes, coordinating manufacturing DHR reviews and ensures required MDR/Vigilance reporting.  Serves as business owner for the TrackWise complaint handling electroni