Sr. Manager / Associate Director - Quality Compliance

Sr. Manager / Associate Director – Quality Compliance Our 3 Core Values Integrity Initiative What You'll Do We are seeking a Senior Manager / Associate Director, Quality Compliance to lead and continuously improve key elements of the company’s Quality Compliance program. This role will serve as a subject matter expert for internal audits, inspection readiness, Quality Management Review, quality metrics and trending, regulatory remediation, and continuous improvement. The position will work cross functionally partnering with Regulatory Affairs, Technical Operations, Manufacturing, Supply Chain, Clinical Operations, and external CDMOs and service providers. Key Responsibilities Own and manage and execute the GxP Internal Audit Programs planning, execution, reporting, CAPA follow up, and trend analysis. Develop and maintain the company’s regulatory inspection readiness program. Support FDA and other regulatory inspections and coordinate responses, commitments, remediation activities, and inspection follow up. Lead or coordinate Quality Management Review (QMR). Develop and maintain meaningful Quality KPIs and KRIs to monitor quality system health and compliance trends. Identify compliance risks through audits, metrics, deviations, CAPAs, complaints, inspections, and other quality data. Lead cross functional continuous improvement and remediation initiatives to strengthen Quality system effectiveness. Monitor FDA regulations, guidance, enforcement trends, and applicable ICH requirements and coordinate compliance gap assessments as needed. Provide compliance oversight for Annual Product Review / Product Quality Review activities and ensure significant trends and actions are appropriately escalated and tracked. Support BLA, pre license inspection, commercial launch, and licensing readiness from a Quality Compliance perspective. Provide senior management with clear visibility into significant compliance risks, remediation status, Quality system performance, and inspection readiness. Support development of a strong, proactive quality culture across the organization. Qualifications Bachelor’s degree in Life Sciences, Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related scientific/technical discipline required; advanced degree preferred. 8+ years of relevant experience for Senior Manager level or 10+ years for Associate Director level within pharmaceutical, biotechnology, biologics, cell/gene therapy, or another highly regulated life-sciences environment. Demonstrated experience in Quality Assurance, Quality Compliance, Quality Systems, manufacturing quality, or auditing. Strong working knowledge of FDA cGMP requirements and applicable ICH guidance. Excellent organizational and negotiation skills. Willingness to travel (10–20%) for business tasks. Salary Range $180,000 - $210,000 Nexcella, Inc. is a subsidiary of Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that filters out non‑specific activation. NXC-201 is being evaluated in the U.S. multi‑center study for relapsed/refractory AL Amyloidosis NEXICART‑2 (NCT06097832), with a registrational design. Interim results were presented at ASCO 2025 in an oral presentation by Heather Landau, M.D. of Memorial Sloan Kettering Cancer Center. NXC‑201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at and #J-18808-Ljbffr Immix Biopharma (Nasdaq: IMMX)