Manager, Quality Assurance

AGC Biologics•Bothell, WA

18d•$94,000 - $129,250

About The Position

The Manager, Lot Disposition leads review, collation, and disposition of manufactured drug substance batches and raw materials. The role ensures timely and compliant batch release while partnering cross-functionally to drive closure of deviations, change controls, and corrective and preventive actions. The manager leads the Lot Disposition team, supports regulatory inspection readiness, and drives continuous improvement to strengthen quality, compliance, and operational effectiveness. The role is part of a Quality Assurance team that supports batch disposition, quality oversight, and quality systems execution for GMP manufacturing operations, collaborating closely with Manufacturing, Quality Control, MSAT, and other site functions.

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 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.