Senior Manager, Quality Document Control & Training (New Haven)

About Celldex

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.

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 documentsCollaborate with cross functional subject matter experts to design and document processes and develop documentationEmploy change management philosophies during implementation of SOPs and support compliance documentationCollects quality data such as audit reports and CAPA and enters into applicable toolsDevelop, track and report key performance and quality indicatorsServes as a super user of electronic tools and technologies supporting Clinical ResearchConverts paper documentation to electronic format where neededSupport regulatory Inspections

Qualifications

Associate Degree/Bachelor degree, or equivalent work experience 8 years of experience performing documentation management in a GCP environmentQuality, process and compliance orientedAbility to manage multiple projects and prioritiesEstablished IT platform skills including Microsoft Office and SmartsheetsExperience with Veeva SystemsExcellent oral and written communication skillsGood interpersonal skills and ability to deal with people at all levels with sensitivity and tactExcellent organizational, multitasking, and priority management skillsCompensationThe expected base salary range for this position is $133,579 to $173,480We 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.Job Summary