Manager, Quality Assurance

AGC Biologics, Inc.; Bothell (WA); On-site; USD 94,000 - 129,000; Full time

Benefits offered by this job

Annual bonus opportunities

Medical, dental & vision coverage

Parental leave

Education assistance

Employee referral and recognition

Job summary

AGC Biologics, Inc. in Bothell, WA is seeking a Manager of Lot Disposition to lead batch review, disposition, and release activities.

This role partners with Manufacturing, QC, MSAT, and other functions to close deviations, CAPAs, and change controls while driving compliance and continuous improvement. You will mentor the Lot Disposition team, ensure timely product release, and support regulatory inspection readiness.

Qualifications

• Requires Bachelor’s degree with 8+ years of industry experience or Master’s with 6+ years.
• Experience supporting batch review, lot disposition, and quality systems within a GMP environment.
• Prior leadership experience managing teams and cross-functional activities.

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 of 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 regulatory inspection readiness activities.
• Manage daily operations and priorities for the Lot Disposition team.
• Allocate resources and ensure work aligns with objectives.
• Coach and develop team members to build capability and performance.

Skills

Leadership

Decision-making

Cross-functional collaboration

GMP knowledge

Prioritization

Education

Bachelor's degree with 8+ years experience

Master's degree with 6+ years experience

Job description

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.

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: Bachelor's degree with 8+ years of industry experience, or Master's 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: $94,000 - $129,250

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.

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. AGC Biologics is Your Friendly CDMO Expert - dedicated partners with the expertise and commitment to support our customers and teams. We work with some of the world's most innovative pharmaceutical companies to develop and manufacture their life-changing drug products.