Feb 21, 2025
CSL
The Opportunity Reporting to the Sr. Director of Product Development Quality, you will be responsible for cross-functional collaborations with Product Development and Research Quality (PDRQ). The successful candidate is expected to implement full control over the phase-appropriate compliance state of the Waltham site, ultimately supporting and expediting the release of Clinical Trial Material (CTM) to clinical subjects and commercial launches. The Role Core Responsibilities: Site lead for all Waltham, MA Quality related responsibilities, leading and coordinating Quality Assurance activities to ensure compliance with company standards (SOPs), internal specifications, GxP requirements, and regulatory guidelines. Ensures effective and communications to authorities (Swiss medic, EMA FDA, etc.), supporting timely product release. Develop and implement strategic goals in alignment with functional leadership priorities. Directs appropriate resourcing model and budget...
Professional Diversity Network
Waltham, MA, USA
Full-Time