Author and review stability reports and summaries for inclusion in INDs, BLAs, Annual Reports, and other regulatory submissions •Lead investigations for significant deviations and quality events, including those at external testing laboratories, ensuring timely and compliant resolution •Drive continuous improvement of processes to maintain compliance while supporting operational and commercial needs •Author and review technical documentation, including protocols, reports, SOPs, test methods, and risk/impact assessments •Initiate and own Quality Management System (QMS) records such as deviations, change controls, and CAPAs related to the stability program. •Author annual report sections with stability summaries and data for regulatory submissions including but not limited to the US Annual Report, Canadian Yearly Biological Product report, and Brazil Annual Product Report •Support responses to health authority questions and information requests •Ensure all strategies align with ICH guidelines and applicable global regulatory requirements.