Job Details

Provide QA oversight of QC-generated data, particularly for product stability and lot release, ensuring compliance with cGMP, FDA, EMA, and other relevant regulations. Collaborate closely with Technical Operations Analytical groups to ensure QC data that support stability and lot release are compliant with specifications and xxx. Oversee all aspects of QC data including review and approval of clinical and commercial stability products, which encompasses all starting materials, drug substance intermediates, drug substance, critical components, drug product intermediates, and drug products for a clinical and commercial program. Review and approve:Stability protocols. OOS/ OOT investigations. Trend reports and final summary reports Oversee timely data evaluation and escalations related to product shelf-life or specification trends. Support oversight of QC activities at CMOs including review of release and stability raw data, data quality, and adherence to timelines. Review and approve SOP...Quality Assurance, Director, Associate, Quality, Technical, Operations, Technology