Manager, Validation

AGC Biologics

Bothell, Washington, United States
$108,080 - $148,610 py
Onsite
Gmp validation
Validation quality systems
Electronic data integrity
This role is responsible for ensuring the effective planning, execution, and governance of validation deliverables in accordance with global regulatory requirements

Job Summary

  • This role is responsible for ensuring the effective planning, execution, and governance of validation deliverables in accordance with global regulatory requirements.
  • The team works cross-functionally with operational and technical partners to support a growing and increasingly complex environment.
  • AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

Matching Summary

This role is responsible for ensuring the effective planning, execution, and governance of validation deliverables in accordance with global regulatory requirements.

Salary

$108,080 - $148,610

Skills & Requirements

Must-have

  • GMP validation
  • Validation Quality Systems
  • electronic data integrity
  • regulatory inspections support
  • cross-functional partnership

Nice-to-have

  • risk-based validation approach
  • continuous improvement initiatives
  • collaborative environment
  • fast-paced operations

Key Requirements

  • 8+ years relevant industry experience with BS/BA
  • 6+ years relevant experience with MS
  • Demonstrated GMP validation experience
  • In-depth knowledge of global regulatory expectations
  • Subject matter expertise in validation and IT systems compliance
  • Hands-on experience with cloud-based and service-based system validation
  • Experience with Computer Software Assurance (CSA)

Work Rights

Not specified

Tailored Resume

Cover Letter