Senior Project Manager – Quality & Regulatory Transformation

Senior Project Manager – Quality & Regulatory Transformation (Consultant)

Engagement Type: Contract / Consultant

Remote but local to Phila, PA preferred for attending key meetings

Position Overview

We are seeking a seasoned Senior Project Manager to join a large-scale Quality Management System (QMS) harmonization initiative and other strategic transformation efforts. This individual will oversee complex, cross-functional workstreams while partnering with Quality, Regulatory Affairs, IT, and business stakeholders to drive successful execution of high-priority deliverables.

The ideal candidate is an experienced leader with a strong background in regulatory response management, crisis management, and delivering projects within highly regulated environments.

Key Responsibilities

• Lead regulatory response activities, ensuring timely coordination and execution of inspection and agency commitments.
• Support crisis management efforts by facilitating rapid response planning, issue resolution, and executive communications.
• Identify, assess, and mitigate project risks while proactively managing critical issues and dependencies.
• Ensure project deliverables are completed on time, within scope, and aligned with business objectives.
• Facilitate project meetings, workshops, governance forums, and executive status updates.
  
  

Required Qualifications

• 10 years of project management experience within the pharmaceutical, biotechnology, or medical device industry.
• Demonstrated success leading enterprise-scale Quality or Regulatory transformation initiatives.
• Extensive experience supporting regulatory inspections, agency responses, and remediation programs.
• Strong crisis management experience with the ability to lead high-visibility, fast-paced initiatives.
• Proven experience managing complex, cross-functional programs involving multiple stakeholders.
• Exceptional communication, facilitation, stakeholder management, and executive presentation skills.
• Demonstrated ability to influence without direct authority and build alignment across organizations.
  
  

Preferred Qualifications

• Experience with global Quality Transformation initiatives.
• Familiarity with GxP, FDA, EMA, and other global regulatory requirements.
• PMP, PgMP, or equivalent project management certification preferred.
• Experience working within a large global pharmaceutical or healthcare organization is highly desirable.
  
  

Key Competencies

• Strategic program leadership
• Regulatory response management
• Crisis management
• Executive stakeholder engagement
• Risk and issue management
• Change management
• Cross-functional leadership
• Strong organizational and communication skills
  
  

This opportunity is ideal for a senior project management professional who excels in complex, highly regulated environments and has a proven track record of delivering transformational initiatives while navigating regulatory and business-critical priorities.

This job opens for applications on 7/8/2026. Applications for this job will be accepted for at least 30 days from the posting date.