QSE7, a Pennsylvania-based consulting company, is seeking a seasoned Senior Project Manager to lead regulatory and compliance engagements for our Life Sciences clients. The ideal candidate will serve as a project manager, strategic thought leader and hands-on project lead, driving complex FDA regulatory programs from initiation through resolution. You will own project outcomes, guide client teams, and bring deep pharmaceutical industry expertise to every engagement.
Detailed Job Responsibilities
As a Senior Project Manager, you will be responsible for:
- 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
Required Experience/Qualifications
- 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
Preferred Experience/Qualifications
- 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)
Travel Requirements
Job responsibilities will primarily be executed from a home office. Candidates located in the Pennsylvania / New Jersey area are strongly preferred. Occasional travel to client facilities may be required based on engagement needs.
About QSE7
Founded in 2016, QSE7 offers innovative and specialized consulting services to FDA-regulated Life Sciences companies. Our areas of focus include program/project management, process analysis, automated business process improvements, data analytics, and reporting. We strive to bring automation and efficiency to our clients' processes by providing high-quality and intuitive solutions in an efficient, comprehensive manner.