Sr. Project Manager - QMS at BD (Becton, Dickinson and Company) San Diego, CA

Job Summary

Sr. Project Manager – QMS responsible for leading the global QMS harmonization initiative from planning and definition through implementation and maintenance. The role focuses on streamlining quality processes, ensuring compliance across all sites, and optimizing efficiency in delivering innovative medical devices worldwide.

• 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 appropriate technology and systems are in place to support the harmonized QMS.
• Support internal and external audits related to the QMS harmonization project and ensure timely resolution of any findings.
• Monitor the effectiveness of the harmonized QMS post‑implementation and drive continuous improvement initiatives.

• Bachelor's degree in engineering, science, or a related field.
• Minimum 11 years of experience in project management, with a significant focus on quality management system implementation or harmonization projects.
• Strong and in‑depth knowledge of global medical device quality management system requirements, including ISO 13485, FDA 21 CFR Part 820, and other relevant regulations.
• Proven experience in analyzing, designing, and implementing harmonized QMS processes and procedures across multiple sites.
• Experience in leading cross‑functional teams and managing stakeholders in a global environment.
• Demonstrated ability to develop and manage detailed project plans, including scope definition, timelines, budgets, and resource allocation.
• Excellent communication, presentation, and interpersonal skills, with the ability to influence and build consensus at all levels of the organization.
• Strong problem‑solving and analytical skills, with the ability to identify root causes and implement effective solutions.
• Ability to work independently and manage multiple priorities in a fast‑paced environment.

• Experience with implementing and integrating QMS software solutions.
• Familiarity with change management methodologies and tools.
• Experience with risk management methodologies and their application within a QMS context.
• Knowledge of Lean or Six Sigma principles and their application to quality system optimization.
• Experience in managing projects involving the integration of quality management systems with other business…