About The Role: The Veeva IT Systems Analyst II is responsible for the maintenance, continuous improvements, and troubleshooting of Forge's Quality Management System, Veeva Vault. The Veeva Vault Quality system includes QualityDocs, Training, QMS, QRM, LIMS, and other modules that may be implemented in the future. This position will support configuration of Veeva Vault Quality and Platform, as well as supporting any future module implementations. This position must work in cross-functional groups including Veeva business administrators, business owners, and technical managers. The position will liaise with Veeva's Managed Services consultants and support technicians. The position will support change control and validation of Veeva Vault Quality.
Responsibilities:- 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, proposed changes, and identify and implement necessary configurations changes to address workflow issues.
- Working with Computer Systems Validation SME to validate changes per GAMP 5 guideline and current Good Manufacturing (cGMP) regulations to maintain validation state and compliance.
- Supporting Veeva Releases and other changes through Change Controls as the system expert.
- Communicating and organizing work with multiple cross-functional teams to support the continuous improvement of Veeva Vault across multiple modules at one time.
- 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. Liaising with other departments for the generation, review and approval and maintenance of such documents.
- Providing support during regulatory inspections and internal audits.
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.
- This is a remote, U.S.-based role with an expectation of traveling to our Columbus, Ohio headquarters at least twice a year.
Preferred Skills:- 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.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.
Work Environment and Physical Demands This position is performed in a remote or virtual work environment using standard computer equipment. The role requires prolonged periods of sitting or standing, frequent computer use, and fine hand manipulation for tasks such as typing and data entry. The individual must be able to communicate effectively via phone, video, and electronic platforms. Occasional minimal lifting (up to 10-15 pounds) may be required (e.g., office supplies). A standard Monday-Friday schedule applies, with flexibility for extended hours as business needs arise.
We’ve Got You Covered: At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one- Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.
Time to recharge- A competitive paid time off plan - because rest fuels innovation.
- 12 weeks of fully paid parental leave so you can focus on family when it matters most.
Rewarding your impact- Annual bonus opportunities for all full-time team members.
- 401(k) with company match to help you plan for the future.
- Special employee discounts, including childcare and dependent care savings.
Your wellness, supported- Onsite fitness facility at The Hearth.
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short and long-term disability coverage to protect your peace of mind.
Fuel for your workday- A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next.
Grow with us- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
