Senior Manager, Quality Document Control & Training

Overview

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

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
• Develops, tracks, and reports 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
• Supports regulatory inspections

Qualifications

• 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