Associate Director, Lot Disposition

Position Summary

The Associate Director, Lot Disposition is responsible for overseeing end-to-end lot disposition activities to ensure timely, compliant, and right-first-time release of Cell and Gene Therapy (CGT) products. This role provides strategic and operational leadership across Quality Assurance, partnering closely with Manufacturing, QC, Supply Chain, MSAT, and Regulatory Affairs. The Associate Director will also serve as the business lead for a high-impact initiative to streamline, digitalize, and automate the lot disposition process to support organizational growth and scalability.

Key Responsibilities

Lot Disposition Leadership

• Oversee all GMP lot disposition activities for Cell & Gene Therapy products, ensuring compliance with global regulatory requirements (FDA, EMA, ICH, etc.).
• Lead cross-functional lot review meetings, coordinate timely resolution of discrepancies, deviations, and analytical issues, and ensure robust documentation packages.
• Maintain oversight of batch record review, CoA/CoC issuance, and final lot release recommendations.
• Ensure readiness for regulatory inspections, partner audits, and internal audits related to lot disposition processes.
• Drive continuous improvement and operational excellence within QA Lot Disposition.

Project Leadership: Streamlining & Automating Disposition

• Serve as the business owner and project lead for a strategic initiative to streamline, digitalize, and automate the CGT lot disposition process.
• Define project scope, requirements, and success metrics in partnership with IT, Digital/Automation teams, and key functional stakeholders.
• Champion implementation of electronic lot disposition workflows, data integrations, dashboards, and document automation tools.
• Identify bottlenecks and root causes in current processes and develop future-state workflows enabling faster, more reliable product release.
• Develop change-management plans to ensure adoption across global teams.

Quality & Compliance Leadership

• Ensure lot disposition processes adhere to internal SOPs, quality standards, and GMP regulations for advanced therapy medicinal products (ATMPs).
• Collaborate with QA Operations and QA Systems to strengthen data integrity, traceability, and risk management practices.
• Review and approve quality records, including deviations, CAPAs, investigations, and change controls impacting product release.
• Support regulatory submissions, annual product reviews, and responses to health authority questions related to release processes.

Cross-Functional Partnership

• Partner closely with Manufacturing, QC, Analytical Development, Supply Chain, MSAT, and Regulatory Affairs to ensure alignment and timely resolution of lot-impacting issues.
• Provide leadership, direction, and development for a team of QA professionals supporting lot disposition activities.
• Communicate program status, risks, and deliverables to senior leadership.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• 8-12+ years of experience in GMP Quality Assurance within biologics, cell therapy, gene therapy, or advanced therapy manufacturing.
• Strong working knowledge of global GMP regulations for CGT/ATMP products.
• Demonstrated experience leading lot disposition or QA operations in a commercial or clinical manufacturing environment.
• Proven success driving process improvements, digital enablement, or automation initiatives within Quality.
• Excellent communication, team leadership, and cross-functional collaboration skills.
• Ability to thrive in a fast-paced, evolving environment with shifting priorities.

Preferred Experience

• Experience with Veeva, MES, QMS, LIMS, EBR solutions, and digital quality tools.
• Prior involvement in tech transfers, new product introductions, or CGT commercialization.
• Strong analytical and project-management skills, including leading cross-functional automation or transformation efforts.

Additional Information:

Base Salary Range: $145,105 - $196,327

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.

Genetix's total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter shutdown, tuition reimbursement & loan repayment assistance, paid parental leave, generous commuter subsidy, and much more."