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.

QSE7, LLC

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