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.
