Detailed Job Responsibilities
- Providing document coordination support to key stakeholders
- Working independently for task execution across multiple workstreams
- Processing documents in a GMP system (ie. Create docs, revise docs, route docs, etc.)
- Representing Document Management on cross-functional workstreams
- Reporting timely updates to senior leadership
- Coordinating project status meetings, developing agendas, facilitating discussions and documenting meeting minutes
- Delivering transparent, timely and effective verbal and written communications to team members, project stakeholders and senior management
- Proactively identifying and escalating risks to key project stakeholders, and defining/executing effective mitigation and contingency strategies
- Leading cross-functional teams, in a matrix environment
- Influencing others beyond own scope and level; leading communications with all stakeholder levels to enable informed decision making
- Driving team accountability to ensure timely execution of work and high-quality deliverables
- Making the complex simple when presenting opportunities and plans to the team and organization
- Leading teams thorough options analysis and driving recommendations
Required Experience/Qualifications
- A B.A. or B.S. degree
- Technical expertise in a Document Management System in a regulated environment
- A minimum of five (5) years of relevant business experience with a minimum of three (3) years of increasing responsibility in the over-the-counter (OTC), consumer products and/or pharmaceutical industries
- Thorough understanding of FDA regulations and guidelines
- Excellent oral, written, presentation communication skills
- Proven record of leading teams and delivering results
- Demonstrated enterprise-wide knowledge and experience leading/motivating cross-functional teams
Preferred Experience/Qualifications
- Demonstrated leadership & influencing skills across various organizational levels
- Familiarity with Microsoft SharePoint, Microsoft Teams and Microsoft Power BI
- Process Excellence or Six Sigma certification
Travel Requirements
Job responsibilities will primarily be executed from a home office. Infrequent travel to client facilities may occasionally be required.
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.