Job Description Summary

We are seeking a highly motivated and experienced Sr.Project Manager to lead a critical initiative focused on harmonizing Quality Management Systems (QMS) with global processes.

This role will be pivotal in streamlining our quality processes, ensuring consistent compliance across all sites, and optimizing efficiency in the delivery of innovative medical devices to patients worldwide. As the Sr. Project Manager - Quality, you will be responsible for the full lifecycle of this complex project, from initial planning and definition through implementation and ongoing maintenance. You will collaborate extensively with cross-functional teams and site stakeholders to develop a unified QMS framework, manage the integration of diverse quality standards and procedures, and drive continuous improvement. The ideal candidate will possess a strong understanding of global medical device regulations, demonstrated expertise in managing complex harmonization projects, and a proven ability to navigate organizational change within a regulated environment. Experience with various quality management standards (e.g., ISO 13485, FDA 21 CFR Part 820, ISO 9001) and QMS integration is essential.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

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

This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through March 31, 2026.

Responsibilities 

• Lead and manage the global QMS harmonization project from initiation to closure, ensuring adherence to timelines, budget, and quality objectives. 

• Develop a comprehensive project plan outlining the scope of harmonization, key milestones, resource requirements, and risk mitigation strategies. 

• Facilitate cross-functional workshops and meetings to analyze existing QMS frameworks across different sites and identify areas for harmonization and standardization. 

• Define and document a unified global QMS framework that aligns with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, ISO 9001) and best practices. 

• Oversee the development and implementation of standardized QMS processes, procedures, and documentation across all relevant sites. 

• Manage the integration of various QMS elements, including document control, change control, CAPA, internal audits, training, and supplier management, into a cohesive global system. 

• Identify and analyze gaps between current state QMS and the target harmonized framework and develop effective remediation plans. 

• Lead the development and execution of a comprehensive communication and change management plan to ensure stakeholder buy-in and successful adoption of the harmonized QMS. 

• Manage and track project progress, providing regular updates to stakeholders on key milestones, risks, and challenges. 

• Identify, assess, and mitigate project risks and issues related to QMS harmonization, developing contingency plans as needed. 

• Collaborate with IT and other relevant departments to ensure the appropriate technology and systems are in place to support the harmonized QMS. 

• Support internal and external audits related to the QMS