[Remote] Sr. Project Manager

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.ResponsibilitiesServing 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 teamsBuilding and maintaining detailed project plans with critical milestones, resource constraints, financial commitments, and key interdependenciesLeading cross-functional client teams and maintaining accountability / momentum throughout the full project lifecycleMaintaining project dashboards and providing timely performance updates to senior client leadership and QSE7 managementProactively identifying and escalating risks to key stakeholders, while defining and executing effective mitigation and contingency strategiesServing as a thought leader and trusted advisor to client executives, translating complex regulatory requirements into clear, actionable project strategiesDeveloping and executing communication strategies that keep all project stakeholders aligned and informedDriving team accountability to ensure timely, high-quality deliverables that meet FDA expectationsSimplifying complex regulatory and operational concepts when presenting opportunities and plans to leadershipLeading "lessons learned" and "best practices" sessions to build client capability and foster continuous improvementContributing to QSE7's internal knowledge base and client strategy through active thought leadership and industry engagementSkillsB.A. or B.S. degreeA minimum of fifteen (15) years of relevant business experience, with significant tenure in large pharmaceutical or life sciences organizationsDeep, hands-on experience managing FDA regulatory responses, including 483 observations, Warning Letters, and consent decree remediation programsDemonstrated ability to lead (not just manage) large cross-functional teams through complex, high-stakes regulatory challengesThorough understanding of FDA regulations, guidelines, CAPA frameworks, and submission requirementsProven track record as a project lead and strategic advisor to senior client or organizational leadershipExcellent oral, written, and presentation communication skillsExperience with project planning software such as MS Project and SmartSheetsDemonstrated enterprise-wide knowledge and experience leading and motivating cross-functional teamsBackground in large pharmaceutical companies (e.g., enterprise-scale manufacturing, quality, or regulatory affairs operations)Located in the Pennsylvania / New Jersey areaPMP, ASQ CQA, or equivalent quality or project management certificationFamiliarity with Microsoft Teams and SharePointExperience supporting Pre-Approval Inspections (PAI) or other FDA facility readiness programsAdvanced degree or regulatory/quality certification (RAC, CQA, or similar)Company OverviewFounded in 2016, QSE7 offers innovative and specialized Information Technology (IT) and Consulting services to Life Sciences companies. It was founded in 2016, and is headquartered in Philadelphia, Pennsylvania, USA, with a workforce of 11-50 employees. Its website is https://www.qse7.com.