Genetix Biotherapeutics
Associate Director, Lot Disposition
Genetix Biotherapeutics, Somerville, Massachusetts, us, 02145
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
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
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.
Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
Interested in building your career at Genetix Biotherapeutics? Get future opportunities sent straight to your email.
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Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
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
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.
Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
Interested in building your career at Genetix Biotherapeutics? Get future opportunities sent straight to your email.
#J-18808-Ljbffr