Senior Director, Product Quality Engineering

Position Summary Senior Director of Cell Therapy Product Quality Engineering leads a global team ensuring cGMP compliance, product quality, and regulatory readiness for BMS. Accountable for global standardization and harmonization of product quality principles, processes, and governance across the cell therapy portfolio. Partners in a matrix environment with Global Product Quality Leads and functional leaders to ensure consistent application of GPQ standards, risk frameworks, and lifecycle strategies. Key Responsibilities Define and implement a global harmonization roadmap for GPQ standards, processes, and tools across sites/programs. Lead a global matrix team of product quality experts to achieve alignment across products. Drive lifecycle platform strategies for Integrated Control Strategy (ICS), Stability, analytical lifecycle management, jurisdictional control, and specification strategy. Harmonize product quality risk assessment (PQRA) methodologies and robustness metrics. Ensure harmonized processes meet global regulatory requirements and support inspection readiness. Partner with CTTO, QA/QC, Regulatory, and Manufacturing Operations to embed harmonized standards into workflows. Foster innovation, agility, collaboration, inclusion, and a compliance/quality mindset. Establish and meet quality performance and compliance metrics aligned with business/financial objectives. Lead internal/external governance meetings (steering committees, partner collaborations) for proactive quality management. Basic Qualifications BS/MS/PhD in Life Sciences (Biology, Chemistry, Engineering) or related field; 12–15+ years GMP Quality; 7+ years people management; 5+ years in cell therapy/gene therapy/advanced biologics manufacturing. Experience leading global quality teams in a matrix environment; hiring/coaching/developing technical talent. Deep cGMP, regulatory, and quality system knowledge for cell and gene therapy manufacturing. Strategic, analytical problem‑solving and decision‑making skills. Strong written/verbal communication across all organizational levels and with external partners. Experience with technical transfers, process qualification, comparability, and validation for new manufacturing technologies. Ability to work in a fast‑paced environment with robust compliance/quality oversight. Experience driving continuous improvement and business process digitization within quality operations. Preferred Qualifications Experience with autologous CAR T, viral vector manufacturing, and quality control equipment/system automation. Product Quality Leadership for cell/gene therapy. Track record supporting product launches, BLA submissions, and regulatory interactions. Combination of quality assurance, quality control, and compliance across process development, MS&T, and external manufacturing. #J-18808-Ljbffr