Senior Manager, Quality Document Control & Training

Celldex Therapeutics•New Haven, CT

8d•$133,579 - $173,480

About The Position

This role supports the Clinical Research organization through document management, data entry, system administration, and compliance reporting within electronic document and learning management systems. The position serves as a subject matter expert for clinical research technologies, including Veeva Systems, while ensuring adherence to GCP, quality, and compliance standards.

Requirements

Associate Degree/Bachelor degree, or equivalent work experience
8 years of experience performing documentation management in a GCP environment
Quality, process and compliance oriented
Ability to manage multiple projects and priorities
Established IT platform skills including Microsoft Office and Smartsheets
Experience with Veeva Systems
Excellent oral and written communication skills
Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
Excellent organizational, multitasking, and priority management skills

Responsibilities

Facilitates documentation generation process in the document management system and supports processes involving controlled documents
Collaborate with cross functional subject matter experts to design and document processes and develop documentation
Employ change management philosophies during implementation of SOPs and support compliance documentation
Collects quality data such as audit reports and CAPA and enters into applicable tools
Develop, track and report key performance and quality indicators
Serves as a super user of electronic tools and technologies supporting Clinical Research
Converts paper documentation to electronic format where needed
Support regulatory Inspections