Takeda's Los Angeles Manufacturing Facility is seeking a Quality Assurance leader to ensure overall quality assurance of Site Teardown and Fractionation Operations, meeting regulatory standards and upholding Takeda's commitment to excellence.
Requirements
- Deep knowledge of FDA, EMA, CFDA, and PDA regulations, including Good Data and Documentation Practices (GDDP) and current Good Manufacturing Practices (cGMP)
- Strong understanding of manufacturing operations, procedures, specifications, and regulatory standards
- Proven analytical and problem-solving skills using DMAIC and Lean methodologies
- Experience with quality systems, including exception management, CAPA, Change Control, and Quality on the Shop Floor
- Yellow Belt or Green Belt training/certification (preferred)
- Results-driven mindset with a focus on continuous improvement and process simplification, including digital innovation
- Strategic execution capability to drive department and site-level initiatives
Responsibilities
- Lead multiple sections or departments within the Quality organization, ensuring product quality outcomes
- Collaborate closely with Manufacturing and Engineering teams to support Quality decisions on the shop floor, ensuring compliance with standards and procedures
- Implement and maintain Quality Systems procedures across departments, driving consistent compliance
- Ensure regulatory conformance across multiple operational areas
- Identify and resolve compliance gaps and risks proactively
- Manage or participate in quality assessments of internal operations and suppliers to evaluate compliance and risk
- Analyze trends and lead initiatives to eliminate recurring quality issues
Other
- Bachelor's degree in science, engineering, or a related technical field (preferred: chemistry or biological sciences)
- 8+ years of relevant experience, including 3+ years in a management role with direct reports
- Ability to lift, push, pull, and carry up to 10 lbs
- Comfortable working in cGMP-controlled environments with specialized gowning and protective gear
- Willingness to work in cold, wet, confined, or temperature-variable conditions
