• Provide Quality partnership and oversight to the Product Development Clinical Supply (PDCS) at the New Haven site and at external CLO/CMO’s.
• The Analytical Sciences Quality Lead will provide quality oversight of internal /external testing, stability, analytical technical transfer and quality systems elements in a matrix environment.

Principal Responsibilities:

• Review of technical documents, analytical method validation and transfers for Phase I to III clinical products (including but not limited to biologics, synthetics, cell & gene therapy as well as combination products).
• Quality oversight of assay validation and transfer programs internally and externally.
• Review and approval of stability reports, analytical development, equipment qualification reports and verification reports.
• Perform data verification on CMC sections for filings based on technical reports.
• Partner with ADQC and PDCS Compliance team to manage the timely completion of QMS records (Change Controls, Deviations, LIRs and CAPA’s) aligned to Global quality metrics goals.
• Proactively manage clinical product quality risks ensuring they are appropriately mitigated, actioned and escalated to senior management as required.
• Supports analytical lifecycle management initiatives.
• Partner with other Quality colleagues on product quality impact assessments, particularly for notifications to management, recalls, etc.