Director, Quality Assurance

Job Summary

We are looking for a Director, Quality Assurance to lead QA operations supporting GMP manufacturing of biologics. This role provides both strategic direction and day‑to‑day leadership, ensuring compliance while enabling efficient manufacturing execution.

You will partner closely with Manufacturing and cross‑functional teams to resolve complex issues, improve quality systems, and strengthen QA’s effectiveness on the production floor. A key focus will be building team capability, driving accountability, and evolving QA into a proactive, business‑aligned function.

About the Quality Assurance Team

You will lead a QA organization responsible for batch release, QA on‑the‑floor support, and quality systems execution. The team partners closely with Manufacturing, Engineering and Technical Operations in a fast‑paced GMP environment and plays a critical role in ensuring compliance and operational performance.

Key Responsibilities

• Lead and develop the QA organization, including direct and indirect reports.

• Define and execute QA strategy, focusing on compliance, efficiency, and continuous improvement.

• Oversee and approve complex quality records (deviations, CAPAs, change controls, validations).

• Serve as final authority for drug substance release.

• Strengthen QA presence on the floor to support real‑time decision‑making.

• Partner with Manufacturing to resolve issues, remove bottlenecks, and improve performance.

• Drive improvements across quality systems and simplify processes while maintaining compliance.

• Represent QA in regulatory inspections, client interactions, and major projects.

• Establish clear expectations, roles, and performance standards within the QA organization.

• Manage departmental priorities, resources, and budget.

Leadership Expectations

• Set clear expectations and hold teams accountable for delivery.

• Coach and develop team members; build a strong leadership bench.

• Drive a culture of ownership, decision‑making, and continuous improvement.

• Build strong partnerships across functions, especially with Manufacturing.

Qualifications & Experience

Required:

• Bachelor’s degree with 12+ years, Master’s with 10+ years, or PhD with 7+ years of industry experience.

• Significant QA leadership experience in biotech/biologics manufacturing.

• Strong understanding of GMP, regulatory requirements, and quality systems.

• Experience supporting drug substance manufacturing.

• Experience with regulatory inspections and complex quality decision‑making.

• Proven ability to lead teams, drive improvements, and influence across functions.

Formalities

Location: Bothell, Washington
Compensation Range : $164,400 - $226,050