Global QMS Harmonization Lead

BD-Totaal; San Diego (CA); On-site; USD 139,900 - 230,800; Full time

Benefits offered by this job

Medical, health, dental

401(k)

Limited-term assignment (to Mar 31, 6)

In-office presence required (min 4 d/w

Job summary

BD is seeking a Sr. Project Manager – QMS to lead a global harmonization initiative, defining the scope and roadmap and ensuring regulatory compliance across sites.

You will drive standardized QMS processes, documentation, CAPA, audits, and supplier management as part of a unified system. The role requires deep experience in ISO 13485, FDA 21 CFR Part 820, and related standards, with a track record of delivering complex global quality projects.

Qualifications

• Bachelor's degree in engineering, science, or a related field.
• 11+ years in project management with focus on quality management system implementation or harmonization.
• Extensive knowledge of global medical device QMS requirements (ISO 13485, FDA 21 CFR Part 820, ISO 9001).
• Experience designing and implementing harmonized QMS processes across multiple sites.
• Experience leading cross‑functional teams in a global context.
• Proven ability to develop detailed project plans (scope, timeline, budget, resources).
• Strong communication, presentation, and stakeholder management skills.
• Problem‑solving with root-cause analysis and corrective actions.
• Ability to manage multiple priorities in a fast‑paced environment.

Responsibilities

• Lead global QMS harmonization project from initiation to closure, meeting timelines, budget, and quality objectives.
• Create a comprehensive project plan with scope, milestones, resources, and risk mitigation.
• Facilitate workshops to analyze QMS across sites and identify harmonization opportunities.
• Define a unified global QMS framework aligned with regulatory requirements and best practices.
• Oversee standardized QMS processes, documentation, and change control across sites.
• Integrate document control, CAPA, internal audits, training, and supplier management.
• Identify gaps and develop remediation plans for current vs target QMS states.
• Drive change management and stakeholder buy‑in for successful adoption.
• Track progress and report milestones, risks, and issues to stakeholders.
• Collaborate with IT to deploy supporting QMS technology and systems.
• Support internal/external audits and resolution of findings.
• Monitor post‑implementation effectiveness and drive continuous improvement.

Skills

Project management

Quality management

Regulatory knowledge

Cross-functional leadership

Communication

Analytical skills

Problem solving

Stakeholder management

Global team leadership

Education

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

Tools

QMS software solutions

Audit management software

Change management tools

Job description

BD is seeking a Sr. Project Manager – QMS to lead a global harmonization initiative, defining the scope and roadmap and ensuring regulatory compliance across sites.

You will drive standardized QMS processes, documentation, CAPA, audits, and supplier management as part of a unified system. The role requires deep experience in ISO 13485, FDA 21 CFR Part 820, and related standards, with a track record of delivering complex global quality projects.