Manager, Validation

AGC Biologics

Bothell, WA, US
Base: $108,080 - $148,610; bonus/equity: not speci...
Onsite
Gmp validation experience in regulated environment
Knowledge of fda and ema global regulatory expectations
Experience with cloud-based system validation
AGC Biologics is seeking a Manager of Validation for their Bothell, WA location, responsible for leading validation activities and ensuring compliance with regulatory standards in a GMP environment. The ideal candidate will have extensive experience in validation within the pharmaceutical sector and will play a crucial role in driving continuous improvement initiatives and supporting regulatory inspections

Job Summary

  • The role is responsible for ensuring the effective planning, execution, and governance of validation deliverables in accordance with global regulatory requirements.
  • This position partners closely with Manufacturing, Engineering, IT, Quality, and external vendors while playing a key role in supporting regulatory inspections.
  • AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

Matching Summary

Match Score: 85

AGC Biologics is seeking a Manager of Validation for their Bothell, WA location, responsible for leading validation activities and ensuring compliance with regulatory standards in a GMP environment. The ideal candidate will have extensive experience in validation within the pharmaceutical sector and will play a crucial role in driving continuous improvement initiatives and supporting regulatory inspections.

Salary

Base: $108,080 - $148,610; Bonus/Equity: Not specified; Benefits: Highly competitive compensation package

Skills & Requirements

Must-have

  • GMP validation experience in regulated environment
  • Knowledge of FDA and EMA global regulatory expectations
  • Experience with cloud-based system validation
  • Computer Software Assurance (CSA) implementation
  • Electronic data integrity expertise

Nice-to-have

  • Strong facilitation and project management skills
  • Strategic understanding of validation lifecycle
  • Exceptional stakeholder interface skills
  • Proven ability to lead and coach teams

Key Requirements

  • Bachelor's degree with 8+ years relevant industry experience
  • Master's degree with 6+ years relevant experience
  • In-depth knowledge of computerized systems compliance
  • Hands-on experience with ERP, LIMS, and QMS systems

Work Rights

Not specified

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