Allotera
careers opportunities

Job openings

Director of Quality

Location: Remote (U.S.-based)

Allotera Therapeutics, Inc. is a clinical-stage biotechnology company developing allogeneic, off-the-shelf CAR-T cell therapies for cancer. The company is advancing Soficabtagene Geleucel, or Sofi-cel, its lead CD7-targeted CAR-T cell therapy, through a global pivotal study for relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. Allotera’s gene-editing and manufacturing approach is intended to address key biological and practical barriers that have limited CAR-T therapy development in T-cell cancers. Headquartered in St. Louis, Missouri, Allotera is working to expand what off-the-shelf cell therapy can mean for patients with aggressive hematological malignancies. For more information, visit www.alloteratx.com.

Job Description

Allotera Therapeutics is seeking an exceptional and highly motivated Director of Quality to strengthen our Quality organization as we advance toward BLA submission and commercial readiness. This fully remote role will drive support with oversight of contract service provider, inspection readiness, lead and perform audits, own authorship and revision of quality procedures, and continuously improve our Quality Management System (QMS), while partnering closely with CMC, Manufacturing, and Regulatory Affairs.

Location: Remote (U.S.-based)

Primary Responsibilities

  • Plan and perform internal, vendor, and CDMO/supplier audits; manage audit findings through root cause analysis, CAPA, and effectiveness verification.
  • Own authorship, review, and revision of Standard Operating Procedures (SOPs) and other controlled quality system documents, ensuring alignment with current regulatory expectations and industry best practice.
  • Review quality and technical documents (e.g., batch records, validation protocols/reports, quality agreements, investigation reports) for accuracy, completeness, and compliance prior to approval or submission.
  • Drive continuous improvement of the QMS — including change control, deviation/CAPA management, document control, and quality metrics/trending — as Allotera scales from clinical to commercial operations.
  • Oversee chain-of-identity/chain-of-custody controls to ensure compliance across sourcing and manufacturing of allogeneic, off-the-shelf cell therapy products.
  • Facilitate quality risk assessments (e.g., ICH Q9) across manufacturing, testing, and supply chain processes, and drive resulting risk-mitigation actions to closure.
  • Ensure data integrity and computerized system compliance (e.g., 21 CFR Part 11, computer system validation) across quality-critical GMP systems.
  • Support BLA-readiness activities, including Quality input to CMC sections, pre-submission gap assessments, and cross-functional readiness reviews.
  • Lead regulatory inspection preparation and manage regulatory inspections (e.g., FDA pre-approval inspection (PAI), pre-license inspection, and for-cause inspections), including mock inspection programs, front-room/back-room readiness, and inspection response coordination
  • Maintain current, working knowledge of evolving FDA, ICH, and applicable global regulations and guidance, and translate regulatory change into updated procedures, training, and risk assessments.
  • Collaborate with internal functional teams to provide Quality guidance and direction on risk management and critical deviation/issue resolution.
  • Prepare and facilitate the Quality Management Review process and present quality metrics, audit outcomes, and inspection-readiness status to leadership.
  • Champion a culture of quality and continuous improvement across the organization.
  • Represent Quality on cross-functional project teams, providing quality input and risk-based guidance as Allotera’s programs advance.

Qualifications

  • BS/MS degree in a scientific discipline with 10-12+ years of applicable Quality experience, including demonstrated people or program leadership.
  • Direct experience supporting a Biologics License Application (BLA), including Quality input to CMC/manufacturing sections and pre-submission readiness activities.
  • Demonstrated experience preparing for and directly managing regulatory inspections (e.g., FDA PAI, pre-license, or for-cause inspections), including mock inspection programs and inspection response.
  • Strong hands-on audit experience — internal, vendor, and CDMO/supplier audits — with the ability to drive findings to root cause and closure.
  • Proven track record authoring, reviewing, and revising SOPs and other quality system documents.
  • Applied, current knowledge of GMP and GLP requirements and applicable global regulations (e.g., 21 CFR Parts 210/211, ICH Q7/Q9/Q10), with the ability to stay current as regulations evolve and apply that knowledge to QMS strategy.
  • Knowledge/experience in cell therapy, biopharmaceutical research, manufacturing, and/or testing is preferred.
  • Knowledge/experience with vendor/supplier oversight is preferred.
  • Working knowledge of donor eligibility and Good Tissue Practice (GTP, 21 CFR Part 1271) requirements is preferred, particularly for allogeneic, off-the-shelf cell therapy products.
  • Knowledge of Good Clinical Practice (GCP) and/or prior experience in Clinical Quality Assurance for cell therapy products is preferred.
  • Experience with electronic Quality Management System platforms (e.g., Veeva Vault QualityDocs) is preferred.
  • Ability and willingness to travel domestically (approximately 10–20%) to support CDMO, vendor, and inspection-related activities.
  • Self-motivated with the ability to work independently in a fully remote capacity, and to operate effectively within an entrepreneurial, fast-paced, collaborative environment.
  • Detail-oriented with strong organizational, analytical, and communication skills.

Apply to: mlewis@alloteratx.com

Scroll to Top