[Hiring] Project Manager, Quality Assurance/ Regulatory Affairs @Henry Schein

Role Description

The position is responsible for managing critical projects for Henry Schein Products Group (HSPG) businesses with a Quality Assurance and Regulatory Affairs (QA/RA) focus. This role works with QA/RA team members as well as other functions to put together key actions items, key dependencies, and timelines to ensure projects are successful.

Qualifications

• Proficiency in the Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams).
• Working knowledge of additional applications such as Visio, Access, Power BI, and SharePoint a plus.
• Experience using quality system electronic applications is a plus.
• Knowledge of EU MDR.
• PMP certification desired.
• Demonstrated ability to lead and manage employees while driving effective and efficient processes.
• Demonstrated record of successfully leading quality improvement projects.
• Ability to effectively solve problems through critical thinking and root-cause analysis with minimal direction.
• Ability to prioritize, multi-task, and adapt to change.
• Ability to work effectively in a team environment and build strong working relationships.
• High degree of initiative and self-motivation with a strong sense of accountability.
• Experience leading audits and interactions with 3rd party regulatory agencies, including Notified Bodies and FDA.
• Typically, 5 or more years of increasing responsibility and complexity in terms of any applicable professional experience; 1 or more years of project management experience desired.
• Medical devices experience a must.
• Thorough knowledge of quality system regulations, i.e., QMSR, ISO 13485, MDSAP, EU MDR, etc.

Requirements

• Lead the planning, execution, and successful delivery of strategic Quality and Regulatory Affairs initiatives, including electronic Quality Management System (eQMS) implementations, QMS remediation programs, quality system integrations, process harmonization projects, and compliance-driven business transformations. (40%)
• Develop and maintain integrated project plans, resource forecasts, budgets, timelines, risk registers, and governance frameworks to ensure projects are delivered on schedule, within scope, and in compliance with applicable requirements. (25%)
• Assess, manage, and escalate project risks, regulatory impacts, resource constraints, and quality-related issues using risk-based decision-making and structured problem-solving methodologies. (15%)
• Establish and monitor project Key Process Indicators (KPIs), dashboards, and executive reporting metrics; communicate project health, key risks, resource needs, and recommendations to senior leadership. (10%)
• Lead Quality and Regulatory integration activities associated with mergers, acquisitions, divestitures, site transfers, and organizational transformations, including gap assessments, remediation planning, and compliance integration efforts. (10%)
• Facilitate project governance meetings, steering committee reviews, and executive updates.
• Promote best practices in project management, quality systems, and regulatory compliance.
• Participate in facility and Quality Management System Regulations (QMSR) inspections by the FDA, Notified Body, and internal GMP audits.
• Participate in special projects and perform other duties as required.

Benefits

• Medical, Dental and Vision Coverage
• 401K Plan with Company Match
• Generous Time Off
• Paid Parental Leave
• Income Protection
• Work Life Assistance Program
• Flexible Spending Accounts
• Educational Benefits
• Worldwide Scholarship Program
• Volunteer Opportunities