Business Application & Systems Administrator
Summary
Manages and optimizes core business applications (Spotfire BI, Project & Portfolio Management, Electronic Lab Notebook, Lab and Image Management) at a life sciences company, handling configuration, CSV/GxP/FDA 21 CFR Part 11 compliance, upgrades, testing, and end-user support.
Job Description
The Business Applications & Systems Administrator is responsible for managing, implementing, and optimizing business applications. The role will develop & coordinate testing with impacted departments, including specifically coordinating with IT and Quality for validation & compliance. Manages business application projects, ensuring effective communication across teams/functions as well as informing management of progress and key issues.
Key Responsibilities
Application Management:
- Administer and maintain core business owned applications (e.g. Project & Portfolio Management, Electronic Lab Notebook, Lab Management, Image Management, Spotfire business intelligence).
Configuration & Customization:
- Configure applications to support business workflows, including directly configuring and through available technical resources.
Compliance & Validation:
- Write test plans and testing scripts in support of Computer System Validation (CSV) team
- Ensure systems meet GxP, FDA 21 CFR Part 11, and other regulatory requirements as required based on application upgrades.
- Collaborate with IT and QA on compliance and security attestations.
Support & Troubleshooting:
- Provide first line support for application-related questions, including directing to appropriate subject matter experts.
Upgrades & Patches:
- Plan and execute upgrades and patches and ensure validation compliance
Data Integrity:
- Ensure data integrity and traceability across systems.
Training:
- Train end-users and maintain user guides.
Qualifications
Bachelor’s degree in Information Technology, Computer Science, or related field.
8+ years in application administration.
Familiarity with validated systems and regulatory compliance.
Strong understanding of GxP, FDA 21 CFR Part 11 compliance.
Excellent problem-solving and communication skills.
Preferred Qualifications:
10+ years in business applications management.
Experience within a life sciences environment.
Experience with cloud-based pharmaceutical applications.
Knowledge of change control in regulated environments.
Familiarity with CSV (Computer System Validation) processes.
Experience with leading cloud based business systems implementation.