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.
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