Senior Quality Associate - Preclinical & Laboratory Quality
CSL · Waltham, Massachusetts, US
Please note we have two openings for this role. Preclinical laboratory QA Staff (Advisor) ensures compliance to GLP, GCLP (ISO/IEC 17025), GRLP and other GxP...
Job description
Please note we have two openings for this role. Preclinical laboratory QA Staff (Advisor) ensures compliance to GLP, GCLP (ISO/IEC 17025), GRLP and other GxP requirements (as applicable). This role will support the implementation of GLP/GCLP quality initiatives, systems, and processes across the relevant R&D Preclinical and clinical lab functions at defined sites, while advancing globally harmonized phase-appropriate quality strategies for research, pre-clinical, and clinical stages of product development. Role will support maintenance of robust quality systems, lead inspection readiness activities, manage regulatory inspections, and follow up on quality actions including corrective and preventive actions (CAPA) to ensure timely and compliant resolution of findings. This role models the CSL Way and promotes a strong quality culture aligned with organizational vision and values to bring durable improvements in quality systems and processes. Responsibilities: Work with R&D partners and stakeholders to establish procedures, standards, and systems according to local and regulatory standards including liaising with R&D departments regarding quality assurance and compliance related issue...