Project Manager – Quality and Regulatory

Project Manager – Quality and Regulatory

Job Posting

The Project Manager – Quality and Regulatory will lead and coordinate projects aimed at Quality Management System (QMS) enhancement initiatives. The project manager will serve as the primary driver of project(s) execution across a group of QMS workstreams, coordinating cross-functional teams and ensuring delivery against defined milestones. This position is defined term for approximately 12 months. While the role is remote, candidates should reside in Eastern Standard Time.

Responsibilities and Essential Duties

• Serve as project manager, owning an integrated schedule, milestone tracking, and status reporting across all QMS workstreams.
• Apply formal PMI-based project management methodology including scope, schedule, risk, issue, and change management disciplines.
• Develop and maintain project-level RAID logs, status dashboards, and executive-level reporting cadence.
• Facilitate reviews and workstream-level working sessions with Quality, Regulatory, Operations, and cross-functional stakeholders.
• Lead project coordination across the following QMS enhancement areas: Product Development Process, Receiving Inspection, Complaints & Vigilance, Validation, Device History Records (DHRs), Inspection & In-Process Controls, Corrective and Preventive Action (CAPA), and Training.
• Support SOP development, gap closure documentation, and audit-readiness activities within scope.
• Develop and present structured status reports to project teams and senior leadership on a defined cadence.
• Escalate risk and issues proactively; recommend resolution paths with supporting analysis.
• Contribute to the ongoing development of PMO tools, templates, and governance processes within Healthmark’s program management function.
• Identify process improvement opportunities within the QMS implementation approach and recommend enhancements.
• Collaborate with Quality Assurance and Regulatory Affairs to ensure all project deliverables meet FDA 21 CFR

Additional Information

This posting describes a defined term role intended to drive QMS-related improvements and regulatory alignment within Healthmark Industries Co., Inc. Location flexibility is noted with remote work and EST residency requirement.