Regulatory IT Business Systems Analyst (Hybrid, CSV/GxP)

Apellis Pharmaceuticals; Waltham (MA); Hybrid; USD 94,000 - 141,000; Full time

Benefits offered by this job

401(k) plan with company match

Flexible time off

Paid family leave

Disability and life insurance

Job summary

A leading biopharmaceutical company is seeking an IT Business Systems Analyst to drive strategic technology initiatives and oversee regulatory systems. This hybrid role based in Waltham, MA, requires 5+ years of experience in the pharma industry, strong communication skills, and a bachelor's degree in a relevant field. The role includes documenting business processes and ensuring compliance with regulations.

Qualifications

• 5+ years in a pharmaceutical/biotech environment required.
• Experience in GxP environment and software validation.
• Experience with business process mapping and gap analysis.

Responsibilities

• Collaborate with business stakeholders to document processes.
• Analyze business needs and identify strategic solutions.
• Manage support activities and incident resolution.

Skills

Regulatory operations knowledge

Customer service orientation

Attention to detail

Team-oriented

Problem solving capability

Strong communication skills

Cross-functional teamwork

Proficient in Microsoft Office

Education

Bachelor's degree in computer science or related disciplines

Tools

Cloud-based applications

Veeva Vault

IQVIA RIMSmart

Job description

A leading biopharmaceutical company is seeking an IT Business Systems Analyst to drive strategic technology initiatives and oversee regulatory systems. This hybrid role based in Waltham, MA, requires 5+ years of experience in the pharma industry, strong communication skills, and a bachelor's degree in a relevant field. The role includes documenting business processes and ensuring compliance with regulations.