Business Application & Systems Administrator

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee, implement, and enhance business applications.

• Design and coordinate testing procedures with relevant departments, including IT and Quality, to ensure validation and compliance.

• Manage projects related to business applications and facilitate communication among various teams and functions.

• Update management on progress and significant issues.

• Administer and sustain essential business applications, such as Project & Portfolio Management, Electronic Lab Notebook, Lab Management, Image Management, and Spotfire business intelligence.

• Configure applications to align with business workflows.

• Develop test plans and testing scripts to support Computer System Validation.

• Ensure that systems adhere to GxP, FDA 21 CFR Part 11, and other regulatory standards.

• Collaborate with IT and QA teams on compliance and security certifications.

• Provide initial application support and direct inquiries to relevant subject matter experts.

• Plan and implement upgrades and patches while maintaining validation compliance.

• Ensure data integrity and traceability throughout systems.

• Train end-users and maintain user documentation.

⛳️ Requirements

• Bachelor’s degree in Information Technology, Computer Science, or a related discipline.

• 8+ years of experience in application administration.

• Knowledge of validated systems and regulatory compliance.

• Strong understanding of GxP and FDA 21 CFR Part 11 compliance requirements.

• Excellent problem-solving abilities and communication skills.

• Preferred: 10+ years of experience in managing business applications.

• Preferred: Experience in a life sciences setting.

• Preferred: Experience with cloud-based pharmaceutical applications.

• Preferred: Understanding of change control processes in regulated environments.

• Preferred: Familiarity with CSV (Computer System Validation) methods.

• Preferred: Experience in leading the implementation of cloud-based business systems.

🏝️ Benefits

• Eligibility for bonus.

• Stock options.

• Comprehensive benefits.

• Opportunity for remote work.

• Occasional travel.