Senior Director, Product Quality Engineering
Location
Seattle, WA
Level
Senior-Level
Department
MedTech
Type
Salary
$239,000 - $290,000
Job Description
Posted on:
2026-03-24
Responsibilities
- Define and implement a global harmonization roadmap for GPQ standards, processes, and tools.
- Lead a global matrix team of product quality experts.
- Drive lifecycle platform strategies for Integrated Control Strategy (ICS) and analytical lifecycle management.
- Harmonize product quality risk assessment methodologies across programs.
- Ensure compliance with global regulatory requirements and support inspection readiness.
- Partner with other departments to embed harmonized standards into workflows.
- Establish and meet quality performance and compliance metrics.
Job Requirements
- BS, MS, or PhD in Life Sciences or related field with 12-15+ years of experience in GMP Quality.
- 7+ years in people management and 5+ years in cell therapy or advanced biologics manufacturing.
- Experience leading global quality teams in a matrixed environment.
- Deep knowledge of cGMP compliance and regulatory requirements.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication skills for effective interaction at all organizational levels.
- Experience with technical transfers and process qualification for new manufacturing technologies.
