Manager, Quality Assurance

AGC Biologics•Bothell, WA

17d

About The Position

The Manager, Quality Assurance leads the review, collation, and disposition of manufactured drug substance batches and raw materials. The role ensures timely, compliant batch release activities and partners cross-functionally to drive closure of deviations, change controls, and corrective and preventive actions. It provides leadership to the Lot Disposition team, supports regulatory inspection readiness, and drives continuous improvement to enhance quality, compliance, and operational effectiveness. The position is part of a Quality Assurance team responsible for batch disposition, quality oversight, and quality systems execution in support of GMP manufacturing operations. The team works closely with Manufacturing, Quality Control, MSAT, and other site functions to support compliant product release and continuous improvement of quality processes. The role is based in Bothell, Washington, and is scheduled Monday through Friday.

Requirements

Bachelor's degree with 8 or more years of industry experience, or a master's degree with 6 or more 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.
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.

Responsibilities

Lead QA support for reviewing and approving 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 aligns with department and organizational objectives.
Coach, mentor, and develop team members to build capability and performance.