Senior Director, GMP Quality Operations & Supplier Quality

Responsibilities Provide end-to-end GMP Quality oversight of CDMOs, contract laboratories, and packaging/labeling vendors supporting clinical and future commercial supply. Lead supplier qualification, performance management, and establishment of robust Quality Agreements. Ensure effective oversight and timely resolution of deviations, investigations, CAPAs, and change controls across external partners. Establish and implement scalable, end-to-end batch disposition processes aligned with global regulatory expectations. Build and operationalize QP release frameworks in collaboration with EU Qualified Persons and external manufacturers. Partner with Technical Operations and CDMOs to support PPQ readiness and execution, ensuring alignment on Quality expectations. Contribute to development of the commercial manufacturing and distribution model, including supply chain readiness. Lead and support inspection readiness activities, including preparation for regulatory inspections across FDA, EMA, PMDA, and other global authorities. Integrate external manufacturing processes into core QMS elements (deviations, CAPA, change control, and product complaints). Develop and implement scalable, phase-appropriate Quality processes to transition from clinical to commercial operations. Foster a Quality culture grounded in problem solving, risk management, continuous improvement, and business partnership. Qualifications Bachelor’s degree in life sciences or related industry experience. 10+ years of GMP Quality experience in biotech/pharma. Experience with external manufacturing and supplier Quality oversight; CMDO experience desired. Direct experience supporting global regulatory inspections, including pre‑approval inspections. Strong knowledge of GMP regulations (FDA, EMA, ICH); GDP and global distribution experience preferred. Experience with batch disposition, QP release, PPQ, and commercial supply readiness. Excellent communication and interpersonal skills; ability to collaborate across departments and external stakeholders. Detail‑oriented with proactive problem‑solving and decision‑making. Certification in quality assurance (e.g., Certified Quality Auditor) desirable. #J-18808-Ljbffr Scorpion Therapeutics