Sr Director Quality Management Systems - BD (Becton, Dickinson and Company) : Job Details

Sr Director Quality Management Systems

BD (Becton, Dickinson and Company)

Job Location : Warwick,RI, USA

Posted on : 2025-02-01T13:24:43Z

Job Description :
BD (Becton, Dickinson and Company) Sr Director Quality Management Systems in Warwick, Rhode Island

Job Description 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 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:

  • Quality Systems: Directs the Surgery-wide strategy for the Quality Management System in compliance with regulations and standards around the world.
  • Document Control: Directs the Surgery-wide document control activities to ensure all applicable documents are controlled and revision histories maintained.
  • CAPA: Directs the Surgery-wide activities to ensure corrective and preventive action is appropriately applied.
  • Situation Analysis/Field Actions: Directs the activities to ensure adequate documentation for the assessment of field issues.
  • Complaint Handling: Directs the Surgery-wide complaint activities to ensure regulatory requirements are fulfilled.
  • Post Market Surveillance: Directs the activities to comply with regulatory requirements for post-market surveillance of Surgery products.
  • Pharmacovigilance Operations: Provide leadership regarding PV activities to ensure accurate maintenance and reporting of adverse drug events.
  • Compliance and Internal Audit: Directs the activities for conducting internal audits across the Business Unit.
  • Analytics: Directs the activities to ensure adequate trend analysis and statistical monitoring of complaints.

    • Qualifications:

  • B.S. and equivalent experience, advanced degree is preferred.
  • American Society of Quality (ASQ) certifications preferred.
  • Minimum 10+ years of experience with FDA regulated industry.
  • Minimum 5+ years of managing a professional staff.
  • Excellent communication skills (verbal, written, and presentation).
  • Ability to interface with regulatory bodies to defend compliance.
  • Travel may be required at 30-40% to support sites across the Business Unit.

    • Why Join Us?

    A career at BD means being part of a team that values your opinions and contributions. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive.

    Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of any protected status.

    #J-18808-Ljbffr
    Apply Now!
    Similar Jobs ( 0)
    -- View More Similar Jobs --