Join Us in Bringing Hope to Life
Our purpose is to bring hope to life by enabling life‑changing therapies for patients around the globe, creating a healthier and happier tomorrow. To advance this purpose, we rely on team members who value excellence, collaboration, and meaningful work. If this resonates with you, we invite you to explore the role further and apply.
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
Who We Are
AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in the United States. From our headquarters in Bothell, Washington, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
We are a collaborative, inclusive, and equal‑opportunity organization where team members are valued for their expertise, teamwork, and ingenuity.
Skills 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
What We Do
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells. Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle. We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance. Visit www.agcbio.com to learn more.
