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Forge Biologics is seeking a Veeva IT Systems Analyst II to maintain, improve, and troubleshoot the company's Quality Management System built on Veeva Vault. The role focuses on the Veeva Vault Quality suite, including QualityDocs, Training, QMS, QRM, LIMS, and future modules. You will work cross-functionally with business administrators, business owners, technical managers, and Veeva's Managed Services consultants to ensure system performance and compliance.
Key responsibilities include:
- Managing and continuously improving the Veeva Vault Platform and all Quality Suite modules
- Designing and implementing configurations for new business requirements and workflow improvements
- Collaborating with Computer Systems Validation SMEs to validate changes per GAMP 5 guidelines and cGMP regulations
- Supporting Veeva releases and changes through formal Change Control processes
- Coordinating work across multiple cross-functional teams on simultaneous improvement initiatives
- Training and advising end users on EDMS and QMS system requirements and workflows
- Developing training modules for EDMS and QMS systems
- Writing and maintaining SOPs and Work Instructions with cross-departmental input
- Providing support during regulatory inspections and internal audits
This is a remote, US-based position with an expectation of traveling to the Columbus, Ohio headquarters at least twice per year. The role requires prolonged computer use, effective communication via phone and video, and occasional minimal lifting of office supplies.
Requirements:
- BS degree in Computer Science, Information Management Systems, Engineering, Life Sciences, or related field; or equivalent work experience
- 3+ years of experience with Veeva Vault Platform configuration
- Strong communication and organizational skills with ability to manage multiple priorities and stakeholders simultaneously
- Demonstrated experience supporting cross-functional teams in a matrixed organization
- Ability to translate complex technical system requirements into practical guidance for non-technical end users
Preferred Skills:
- Familiarity with Veeva Vault Quality modules (QualityDocs, Training, QMS, QRM, LIMS)
- Veeva Vault Platform White Belt Certification or other accredited Veeva certification
- Experience with implementation, validation, and maintenance of Computer Systems in regulated industries (FDA, biotech, pharma)
- Project management experience
- GAMP5, ITIL, or other IT best practice training or certification
