Apogee Therapeutics

Director, Computer System Validation - Quality Assurance (CSV QA)

Apogee Therapeutics

Overview

Director of CSV QA providing strategic leadership and oversight of validation processes.

Ideal candidate has 10+ years in CSV with leadership experience in biotech or pharma.

200k usd / yearremoteseniorEnglish

Locations

  • United States

Requirements

  • Bachelor's degree required
  • Minimum 10 years of experience in CSV
  • Leadership experience in quality assurance required

Responsibilities

  • Lead and manage CSV QA function
  • Develop and implement CSV strategies
  • Oversee validation activities
  • Collaborate with cross-functional teams
  • Drive improvements in CSV processes
  • Ensure compliance with regulatory requirements
  • Lead root cause analysis and CAPA investigations
  • Support vendor assessments and audits

Benefits

  • Flexible PTO
  • Market competitive compensation
  • Health, welfare & retirement benefits
  • Performance bonus
  • Equity grant opportunities
  • Company-wide shutdowns