Job Description Summary

Job Description

Be 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.

The Director, Quality and Regulatory Compliance, Compliance Programs is responsible for helping to shape, implement and support the maintenance of the BD Q&RC compliance programs. This role contributes to the definition of the strategy and determines the tactics required to execute various elements of the program. Through outstanding communication, effective problem solving and active management of ambiguous situations, the Director, Compliance Programs provides heightened oversight and governance of compliance recovery programs. 

The Director works directly with business units and sites to drive enhanced quality and regulatory compliance through coordination, tracking and monitoring of health authority responses, commitments and inspection readiness. 

This role requires demonstrated experience with the US FDA GXP regulations and have a working knowledge on quality matters involving the design, development, manufacture and distribution of medical devices, combination products, IVDR, and drug products.  

The Director will report directly to the VP Quality and Regulatory Compliance and is a member of the Central Quality & Regulatory Compliance Leadership team. 

Responsibilities: 

• Support the Quality & Regulatory Compliance Leadership Team in designing and implementing compliance programs 

• Provides tactical oversight and tracking of planning and execution of recovery activities

• Acts as an independent reviewer/approver on CAPAs and quality plans for assigned compliance recovery programs 

• Works with business unit/site leadership to ensure adequate and capable associates are allocated to quality and regulatory compliance remediations 

• Provides guidance to ensure timely execution of activities defined for compliance programs.  Ensures compliance program activities align with relevant regulations and BD global processes

• Escalates risks to timely and effective completion of compliance programs, including prioritization, resource, capability and documentation concerns

• Develop and maintain a set of tools and templates for reporting on status of compliance programs to various levels of management

• Perceived as thought leader possessing subject matter expert knowledge of global regulations 

• Demonstrates a commitment to service, organization values and professionalism through appropriate conduct and demeanor always

• Operates with the highest levels of ethics and integrity

• Strong problem solving and analytical skills

• Maintains confidentiality and al