Sr. IT Analyst (Biotech)

TL;DR

Sr. IT Analyst (Biotech): Managing quality deviations and regulatory compliance for Cell and Gene Therapy (CGT) systems with an accent on GxP standards and risk management. Focus on leading Root Cause Analysis (RCA), implementing CAPA, and ensuring the integrity of integrated applications within a highly regulated environment.

Location: Hybrid (up to 2 days remote per week) or On-Site in Boston, MA

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Manage quality deviations and the deviation lifecycle for CGT applications.
• Lead investigations, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA) to address quality issues.
• Collaborate cross-functionally to triage quality events and perform risk assessments.
• Ensure strict adherence to Quality processes, SOPs, and 21 CFR Part 11 regulations.
• Communicate complex and time-sensitive information to senior DTE and Quality leadership.
• Build metrics and perform trend analysis on DTE quality events.

Requirements

• Bachelor's degree in Computer Science, software engineering, or a related technical field.
• 5+ years of relevant work experience.
• Experience in the Biotech or Pharmaceutical industry.
• Knowledge of GxP compliance and experience working with GxP IT systems and SaaS vendors.
• Experience with 21 CFR Part 11 regulations and Quality/Risk management portals.
• Must be based in Boston, MA.

Nice to have

• Experience with Veeva QMS or SNOW QRM.
• Experience in Cell and Gene Therapy (CGT) or CGMP Quality exposure.
• Technical writing experience.

Culture & Benefits

• Competitive total rewards including annual bonus and annual equity awards.
• Comprehensive medical, dental, and vision benefits.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• Educational assistance programs including student loan repayment.
• 401(k) plan and commuting subsidy.
• Hybrid work flexibility options.