Sr. Project Manager – Quality

BD; United States; Remote; USD 80,000 - 130,000; Full time

Job summary

An established industry player is seeking a highly motivated Sr. Project Manager to lead a pivotal initiative in harmonizing Quality Management Systems across global processes. This role is crucial for streamlining quality processes and ensuring compliance in delivering innovative medical devices worldwide. The ideal candidate will have extensive experience in managing complex projects within regulated environments and a strong understanding of medical device regulations. Join a supportive environment that fosters growth and innovation, where your contributions will make a significant impact on global health solutions.

Benefits

Medical Insurance

Dental Insurance

401k Plan

Flexible Work Arrangements

Qualifications

• 8+ years in project management focused on QMS implementation.
• Strong knowledge of global medical device regulations.
• Experience in leading cross-functional teams globally.

Responsibilities

• Lead global QMS harmonization project from initiation to closure.
• Develop project plans outlining scope, milestones, and risks.
• Facilitate workshops to analyze and harmonize QMS frameworks.

Skills

Project Management

Quality Management Systems (QMS)

ISO 13485

FDA 21 CFR Part 820

Change Management

Risk Management

Lean Six Sigma

Stakeholder Management

Education

Bachelor's degree in engineering or science

Tools

QMS Software Solutions

ERP Systems

PLM Systems

Job description

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

1. Lead and manage the global QMS harmonization project from initiation to closure, ensuring adherence to timelines, budget, and quality objectives.
2. Develop a comprehensive project plan outlining the scope of harmonization, key milestones, resource requirements, and risk mitigation strategies.
3. Facilitate cross-functional workshops and meetings to analyze existing QMS frameworks across different sites and identify areas for harmonization and standardization.
4. 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.
5. Oversee the development and implementation of standardized QMS processes, procedures, and documentation across all relevant sites.
6. Manage the integration of various QMS elements, including document control, change control, CAPA, internal audits, training, and supplier management, into a cohesive global system.
7. Identify and analyze gaps between current state QMS and the target harmonized framework and develop effective remediation plans.
8. 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.
9. Manage and track project progress, providing regular updates to stakeholders on key milestones, risks, and challenges.
10. Identify, assess, and mitigate project risks and issues related to QMS harmonization, developing contingency plans as needed.
11. Collaborate with IT and other relevant departments to ensure the appropriate technology and systems are in place to support the harmonized QMS.
12. Support internal and external audits related to the QMS harmonization project and ensure timely resolution of any findings.
13. Monitor the effectiveness of the harmonized QMS post-implementation and drive continuous improvement initiatives.

Qualifications

• Bachelor's degree in engineering, science, or a related field.
• Minimum 8 years 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.

Desired Skills

• 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 systems (e.g., ERP, PLM).
• Proven track record of successfully navigating complex organizational structures and cultural differences in global projects.
• Project Management Professional (PMP) certification or equivalent.
• Experience with audit management processes and software.

Additional notes regarding workplace arrangements, vaccination policies, and company culture are included in the original description but are not essential for the core job overview and responsibilities.