Director, Quality Assurance
Job Location:
Bothell, WA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
Join Us in Bringing Hope to Life
Our purpose is to bring hope to life by enabling lifechanging 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 daytoday leadership ensuring compliance while enabling efficient manufacturing execution.
You will partner closely with Manufacturing and crossfunctional teams to resolve complex issues improve quality systems and strengthen QAs effectiveness on the production floor. A key focus will be building team capability driving accountability and evolving QA into a proactive businessaligned function.
About the Quality Assurance Team
You will lead a QA organization responsible for batch release QA onthefloor support and quality systems execution. The team partners closely with Manufacturing Engineering and Technical Operations in a fastpaced 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 realtime decisionmaking.
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 decisionmaking and continuous improvement.
Build strong partnerships across functions especially with Manufacturing.
Qualifications & Experience
Required:
Bachelors degree with 12 years Masters 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 decisionmaking.
Proven ability to lead teams drive improvements and influence across functions.
Formalities
Location: Bothell Washington
Compensation Range : $164400 - $226050
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 lifechanging advanced biologics for some of the worlds 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 equalopportunity organization where team members are valued for their expertise teamwork and ingenuity.
Required Experience:
Director
