Veeva IT Systems Analyst II

The role

The Veeva IT Systems Analyst II manages the maintenance, continuous improvement, and troubleshooting of the Veeva Vault Quality Management System. This role supports configuration of Veeva Vault Quality and Platform and works with cross-functional groups and Managed Services consultants.

What you will do

• Management and continuous improvement of the Veeva Vault Platform and all modules within the Veeva Vault Quality Suite.
• Designing and implementing configurations within Veeva Vault for new business requirements and workflow issues.
• Working with Computer Systems Validation SME to validate changes per GAMP 5 guideline and cGMP regulations.
• Supporting Veeva Releases and other changes through Change Controls.
• Communicating and organizing work with multiple cross-functional teams.
• Training, supporting and advising Veeva end users on EDMS and QMS system requirements and workflows.
• Developing training modules for EDMS and QMS.
• Writing SOPs and Work Instructions.
• Providing support during regulatory inspections and internal audits.

Required qualifications

• BS Degree in Computer Science, Information Management Systems, Engineering, Life Sciences or a related field; or equivalent work experience.
• 3+ years of experience with Veeva Vault Platform configuration experience.
• Strong communication and organizational skills with the 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.

Nice to have

• Familiarity with Veeva Vault Quality modules (i.e., QualityDocs, Training, QMS, QRM, LIMS).
• Veeva Vault Platform White Belt Certification or other accredited Veeva certification.
• Experience with the implementation, validation, and maintenance of a Computer System in an regulated industry (FDA, biotech, pharma, etc.).
• Project management experience.
• GAMP5, ITIL, or other IT best practice training or certification.

Benefits

• Health, dental and vision insurance start your first day with 90% of premiums covered for you and your family.
• Competitive paid time off plan.
• 12 weeks of fully paid parental leave.
• Annual bonus opportunities.
• 401(k) with company match.
• Special employee discounts, including childcare and dependent care savings.
• Onsite fitness facility at The Hearth.
• Mental health counseling and financial planning services through Employee Assistance Program.
• Employer-paid short and long-term disability coverage.
• Fully stocked kitchen with free snacks and beverages.
• Ongoing professional development resources, training, and mentorship programs.

About the company

Forge Biologics aims to enable access to life-changing gene therapies. The team works out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio.