Quality Systems IT Manager

Legend Biotech; Franklin Township (NJ); On-site; USD 90,000 - 150,000; Full time

Job summary

A forward-thinking company is seeking a Quality Systems IT Manager to oversee critical GxP computerized systems. This role involves managing IT platforms like Veeva vaults, ensuring compliance, and supporting strategic projects. The ideal candidate will have extensive experience in regulated environments, strong project management skills, and a deep understanding of GxP regulations. Join an innovative team dedicated to enhancing quality systems and driving operational excellence in the biotech industry. This is an exciting opportunity to make a significant impact in a dynamic and growing field.

Qualifications

• 10+ years of experience in GxP computerized systems within biotech or pharma.
• Veeva Certification and experience managing Veeva platforms.

Responsibilities

• Lead and manage IT platforms/systems including Veeva vaults.
• Oversee change management activities and support operations.

Skills

Project Management

Communication Skills

Organizational Skills

Data Integrity

Knowledge of GxP Regulations

Education

Bachelor's Degree in Life Science or IT

Advanced Degree

Tools

Veeva Vault

Validation Lifecycle Management Systems

Electronic QMS

Document Management Systems

Microsoft Office

Job description

Legend Biotech is seeking a Quality Systems IT Manager as part of the IT team based in Somerset, NJ.

Role Overview

The Quality Systems IT Manager is responsible for managing and supporting critical GxP computerized systems at the system and platform level. This role involves developing, enhancing, and supporting validated computerized systems that support GxP activities, playing a vital role in strategic projects and regulatory compliance.

Key Responsibilities

1. Leading and managing IT platforms/systems, including Veeva vaults (Quality, RIM, Clinical).
2. Overseeing change management activities to support operations, expansion, and optimization based on business requirements and vendor updates.
3. Participating in the development and execution of strategies, plans, and validation deliverables for computerized systems.
4. Collaborating with software vendors, IT, and business teams to support, enhance, and implement systems.
5. Managing validation documentation and deliverables, maintaining readiness for inspections.
6. Handling integrations between Veeva platforms and Learning Management Systems.

Requirements

1. Bachelor’s degree in Life Science, IT, or related field; advanced degree preferred.
2. Veeva Certification.
3. 10+ years of experience with computerized systems in regulated GxP environments within biotech or pharma industries.
4. Experience managing Veeva vaults and platforms, and utilizing Validation Lifecycle Management Systems.
5. Knowledge of GxP regulations, CSV, SDLC, and industry best practices.
6. Experience with GxP applications in Cell Therapy or Biologics manufacturing is a plus.
7. Strong project management, communication, and organizational skills.
8. Proficiency in Microsoft Office, IT management platforms, and Veeva Vault management.
9. Understanding of Data Integrity, 21 CFR Part 11, Annex 11, and GAMP principles.
10. Experience with electronic QMS, VLMS, and Document Management systems.

Additional Information

Legend Biotech is an equal opportunity employer committed to diversity and inclusion. We maintain a drug-free workplace.