Project Manager Administrator

Job Description

Job Description

About QualityHub

QualityHub is an Employee-owned (ESOP) premier Life Science consulting firm dedicated to providing innovative solutions to clients across the pharmaceutical, biotechnology, and medical device industries. Our mission is to drive quality, compliance, and business excellence, helping organizations navigate complex regulatory environments and achieve commercial success.

We serve clients worldwide providing audits and consulting performed by ex-FDA and ex-industry experts. Our services include addressing complex situations like FDA warning letters, product recalls, and optimizing quality systems, as well as offering interim professional staffing solutions for key projects and vacancies.

Role Overview

This Project Manager Administrator is responsible for providing day-to-day support for facilitating client and consultant (contractor) communication, ensuring client deliverables are provided in a timely manner, tracking project status from initiation through closure, reporting on internal and external project metrics, assist in control internal documentation and reference libraries, providing QualityHub operational support, and assist in the planning of services such as audits, remediation projects, and Quality/Regulatory/Clinical Consulting Services.  

Key Responsibilities 

* Support the Sr. Managers within the Consulting Services Department and other QualityHub Managers, as needed, in the planning, execution, and monitoring of consulting services and consulting projects. 

* Provide project management support, including tracking project status, updating and reporting on project metrics, assisting with project start-up and closure. Develop appropriate PM tools to accomplish this. Help compile project analytical data to assist in progress tracking and management updates.

* Schedule and host project-related meetings with the QualityHub consultants (contractors) and, in the intermittent cases were QualityHub management is unable to attend these meetings, communicate updates and concerns to QualityHub management following the meeting.

* Attend weekly/Bi-weekly project update meetings and project planning meetings. Prepare, file, and distribute meeting minutes. Track action item and prompt action item owners as needed to complete action items.

* Plan, track and align consultant deliverables based on project scope. Assist in performing quality assurance oversight as needed.

* Track and monitor the receipt and filing/archiving of consultant/contractor deliverables, including weekly status reports, trip reports, client memos, work product, client quality/project plans, etc.

* Maintain and develop relationships with consultants on assignment and assist with the resolution of issues, escalating to the CS and BD Department Heads, when appropriate.

* Maintain the client relationship throughout the project lifecycle; Function, and, as necessary, act a liaison between the client, consultants, and QualityHub management.

* Assist managers on a variety of tasks related to project schedules, workflow, documentation, as well as communication between the consulting team, clients and QualityHub staff.

* Organize SharePoint files and controlled access/permissions for project document control.

* Help to develop surveys, metrics, and post-project assessments to gauge client satisfaction and consultant experience with QualityHub.

* Assist managers, on an as-needed basis with tasks such as on-boarding and off-boarding consultants, interviewing consultants, helping format project and audit plan/reports and other deliverables, drafting initial SOWs an PWO, setting up and hosting meetings, cleaning-up/preparing slides decks for training, organizing compilation and delivery of training materials to clients, supporting tasks to facilitate QHub attendance and presentation at conferences and workshops, and other administrative tasks to help QualityHub meet objectives.

* Assist Quality Manager in maintaining QualityHub’s reference libraries of relevant regulations, standards, guidelines, and technical reports. Coordinate purchase of needed standards to support consulting projects.

*Manage risks and issues; escalating these to the appropriate QualityHub Management staff, as necessary. Execute and document corrective actions as needed.

* Any other tasks as assigned by executive management or other senior leadership.

* While work is anticipated to be remote; ability to travel if needed is beneficial (less than 10% travel anticipated). 

Qualifications

Education and Experience:

* Bachelors (mandatory) in life sciences, project management, public relations, or business, and a Quality background a plus.

* 5+ years’ experience working within FDA regulated industry, particularly in the quality, regulatory, compliance areas.

* Experience in the management of projects, documents, and deliverables related to quality, regulatory, and/or compliance within the life-science industry.

Required Skills:

* Excellent organizational, and time management skills are required.

* Strong ability to interface with all levels of the organization and with Clients.

* Excellent verbal and written communications skills is a must, especially as it relates to technical writing.

* Ability to multitask in a fast-paced environment.

* Quick learner, strong analytical and problem-solving skills, and attention to detail.

Preferred Qualifications:

* Experienced in planning and monitoring projects use common project management monitoring and reporting tools. 

* Completed training to GMP/Quality Management Systems and/or ISO requirements relevant to the life-science industry (21 CFR 820, 21 CFR 210/211, ISO-13485, ISO-14971, ICH, etc.) 

Work Environment:

Primarily remote with intermittent travel required to the corporate office in Orlando, Florida. Occasional travel (Up to 10% travel)