Senior Manager, Quality Document Control & Training

Overview

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

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

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

CompensationThe expected base salary range for this position is $133,579 to $173,480

We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.