Note: The job is a remote job and is open to candidates in USA. QSE7 Consulting is a Pennsylvania-based consulting company seeking a seasoned Senior Project Manager to lead regulatory and compliance engagements for Life Sciences clients. The role involves driving complex FDA regulatory programs, guiding client teams, and ensuring project outcomes align with regulatory requirements.

Responsibilities

• Serving as the primary project lead on complex regulatory engagements, including helping facilitate and coordinate responses to the FDA (e.g., 483 observations, warning letters, consent decree remediation programs, etc.)
• Developing and driving comprehensive regulatory response strategies in close collaboration with client quality, regulatory affairs, and executive leadership teams
• Building and maintaining detailed project plans with critical milestones, resource constraints, financial commitments, and key interdependencies
• Leading cross-functional client teams and maintaining accountability / momentum throughout the full project lifecycle
• Maintaining project dashboards and providing timely performance updates to senior client leadership and QSE7 management
• Proactively identifying and escalating risks to key stakeholders, while defining and executing effective mitigation and contingency strategies
• Serving as a thought leader and trusted advisor to client executives, translating complex regulatory requirements into clear, actionable project strategies
• Developing and executing communication strategies that keep all project stakeholders aligned and informed
• Driving team accountability to ensure timely, high-quality deliverables that meet FDA expectations
• Simplifying complex regulatory and operational concepts when presenting opportunities and plans to leadership
• Leading "lessons learned" and "best practices" sessions to build client capability and foster continuous improvement
• Contributing to QSE7's internal knowledge base and client strategy through active thought leadership and industry engagement

Skills

• B.A. or B.S. degree
• A minimum of fifteen (15) years of relevant business experience, with significant tenure in large pharmaceutical or life sciences organizations
• Deep, hands-on experience managing FDA regulatory responses, including 483 observations, Warning Letters, and consent decree remediation programs
• Demonstrated ability to lead (not just manage) large cross-functional teams through complex, high-stakes regulatory challenges
• Thorough understanding of FDA regulations, guidelines, CAPA frameworks, and submission requirements
• Proven track record as a project lead and strategic advisor to senior client or organizational leadership
• Excellent oral, written, and presentation communication skills
• Experience with project planning software such as MS Project and SmartSheets
• Demonstrated enterprise-wide knowledge and experience leading and motivating cross-functional teams
• Background in large pharmaceutical companies (e.g., enterprise-scale manufacturing, quality, or regulatory affairs operations)
• Located in the Pennsylvania / New Jersey area
• PMP, ASQ CQA, or equivalent quality or project management certification
• Familiarity with Microsoft Teams and SharePoint
• Experience supporting Pre-Approval Inspections (PAI) or other FDA facility readiness programs
• Advanced degree or regulatory/quality certification (RAC, CQA, or similar)

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