Sr. Project Manager – QMS

BD; United States; Remote; USD 109,000 - 181,000; Full time

Job summary

A leading medical technology company seeks a motivated Senior Project Manager to streamline global Quality Management Systems (QMS). The role involves overseeing the harmonization project from planning to execution, ensuring compliance with regulations. Ideal candidates will have 11 years experience in project management within a regulated environment, strong problem-solving skills, and expertise in quality management standards. Join a dynamic team and contribute to delivering innovative medical devices worldwide.

Benefits

Medical benefits

401k

Dental benefits

Qualifications

• Minimum 11 years experience in project management focused on quality management systems.
• Strong understanding of global medical device regulations.
• Experience in leading cross-functional teams.

Responsibilities

• Lead and manage the QMS harmonization project from initiation to closure.
• Develop a comprehensive project plan outlining scope, milestones, and risks.
• Facilitate workshops to analyze existing QMS frameworks and identify harmonization areas.

Skills

Project Management

Compliance Management

Cross-functional Team Leadership

Problem-solving

Quality Management Systems Integration

Education

Bachelor's degree in engineering, science, or related field

Job description

Job Description SummaryWe 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 harmonization project and ensure timely resolution of any findings.

• 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 11 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.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. 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. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Required Skills

Optional Skills

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Primary Work LocationUSA CA - San Diego TC Bldg C&D Additional Locations Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salaryor hourly rateranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed.The salaryor hourly rateoffered to a successful candidate is based on experience, education, skills, andany step rate pay system of the actualwork location, as applicable to the role or position.Salaryor hourly payranges may varyfor Field-based and Remote roles.

Salary Range Information

$109,700.00 - $180,800.00 USD Annual