Project Manager, Quality Assurance/ Regulatory Affairs

JOB OVERVIEW:

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.

KEY RESPONSIBILITIES:

• 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%)

Other Duties may include:

• 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 Food and Drug Administration (FDA), Notified Body and internal Good Manufacturing Practice (GMP) audits.
• Participates in special projects and performs other duties as required.

SPECIFIC KNOWLEDGE & SKILLS:

• Proficiency in the Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams). Working knowledge of additional applications such as Visio, Access, Power Bl 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 problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence.
• 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, United States Food & Drug Administration (FDA), etc.
• 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, Medical Device Single Audit Program (MDSAP), European Union (EU) Medical Device Regulation (MDR), etc.
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GENERAL SKILLS & COMPETENCIES:

• Strong understanding of industry practices High proficiency with tools, systems, and procedures Good planning/organizational skills and techniques Good decision making, analysis and problem solving skills with ability to multi-task Strong verbal and written communication skills Good presentation and public speaking skills Good interpersonal skills Good conflict resolution skills and ability to deliver difficult messages Ability to build partnerships at all levels within the company, begin to build partnerships externallyResolve complex issues in effective ways

MINIMUM WORK EXPERIENCE:

• Typically 5 to 7 or more years of increasing responsibility in terms of any applicable professional experience.

PREFERRED EDUCATION:

• Typically a Bachelor's Degree or global equivalent in related discipline. Master's degree or global equivalent a plus. May hold one or more industry certifications; professional certification may be required to advance.

TRAVEL / PHYSICAL DEMANDS:

• Travel typically less than 10%. Office environment. No special physical demands required.

KNOWLEDGE:

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