Job SummaryWe 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 TeamYou will lead a QA organizatio
n 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 & ExperienceRequired:- 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.
FormalitiesLocation: Bothell, Washington
Compensation Range : $164,400 - $226,050
