Manager, Quality Assurance

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 Manager Lot Disposition to lead the review collation and disposition of manufactured drug substance batches and raw materials. This role is responsible for ensuring timely and compliant batch release activities while partnering cross-functionally to drive the closure of deviations change controls and corrective and preventive actions.

The Manager Lot Disposition provides leadership to the team supports regulatory inspection readiness and drives continuous improvement initiatives to enhance quality compliance and operational effectiveness.

About the Quality Assurance Team

You will join a Quality Assurance team responsible for batch disposition quality oversight and quality systems execution in support of GMP manufacturing operations. The team partners closely with Manufacturing Quality Control MSAT and other site functions to ensure compliant product release and continuous improvement of quality processes.

Key Responsibilities

• Lead QA support for the review and approval of batch records and related manufacturing documentation.
• Review and approve executed batch records and product testing records.
• Perform lot disposition activities for manufactured drug substance and raw materials.
• Review and approve moderate-complexity deviations change controls and associated CAPAs.
• Review and approve validation documents.
• Partner with cross-functional teams to investigate and resolve quality and compliance issues.
• Drive continuous improvement initiatives to enhance quality systems compliance and efficiency.
• Represent QA on cross-functional project teams and support moderately complex projects.
• Lead management of lot disposition metrics and performance reporting.
• Support and facilitate regulatory inspection readiness activities.
• Manage daily operations and priorities for the Lot Disposition team.
• Allocate resources and ensure work is completed in alignment with department and organizational objectives.
• Coach mentor and develop team members to build capability and performance.

Skills

• Ability to lead and develop professional employees in a regulated environment.
• Strong decision-making and problem-solving skills.
• Effective collaboration and communication across functions.
• Strong knowledge of GMP quality systems and batch disposition processes.
• Ability to manage multiple priorities and drive results in a fast-paced environment.

Qualifications & Experience

Required:

• Bachelors degree with 8 years of industry experience or Masters degree with 6 years of industry experience. Equivalent education and experience may be considered.
• Experience supporting batch review lot disposition and quality systems within a GMP environment.
• Prior leadership experience managing teams and cross-functional activities.
• Strong knowledge of deviations CAPAs change controls and validation activities.

Formalities

Location: Bothell WA

Schedule: Monday through Friday

Compensation: $94000 - $129250

We offer a comprehensive Total Rewards package that may include annual bonus opportunities paid time off medical dental and vision coverage parental leave education assistance employee referral and recognition programs and additional wellbeing benefits. Eligibility and benefits may vary based on role location and employment status.

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:

Manager