Amy Morse Email & Phone Number

• Manage internal audit schedule and execute internal audits to assess the health of the QMS.
• Performed vendor qualification activities, including documentation audits, to onboard and re-qualify GXP vendors.
• Provide support and oversight of training program including creation of training content, maintenance of training catalog and launching training materials.
• Perform process map activities to support continuous improvement of Recursion’s SOPs

• Work with Apellis Supplier Quality team to facilitate CSP audit follow-up including communication of audit findings, CAPA response receipt and follow-up, ensuring critical timelines are met and responses are adequate.
• Work with cross-functional team to compile and provide relevant batch and quality documentation to Strategic Business Partners
• Coordinate review and approval of Quality Events by Strategic Business Partners in accordance with strict timelines related.
• Track progress of requests to/from CSP and Strategic Business Partners, including monitoring status and due dates of action items to drive compliance and on-time completion of activities.
• Manage processes and communications with Strategic Partners to ensure compliance with Quality Technical Agreements
• Monitor timelines and engages business process owners to track progress.

Orlando, Florida, United States

• QA lead for commercial Finished Goods product launch and process validation activities
• Perform disposition activities for commercial products in alignment with internal processes and global regulations – Experience with Drug Substance and Finished Good disposition
• Quality oversight of artwork review, approval and implementation
• Provide quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS and OOT investigations ensuring appropriate CAPA actions are identified
• Prioritize batch disposition activities with cross-functional teams to ensure supply needs are met
• Identify, assess, communicate and mitigate any risks in alignment with internal processes

Boston, Massachusetts, United States

• Analyze data to identify risk profile for compliance and efficiency projects through current state assessments
• Product Complaint, Inspection, Regulatory Surveillance and Mock Recall Support
• Provide guidance for improvements to the Quality Management System
• Performed validation activities for system updates

Boston, Massachusetts, United States

• CMC Document Control Business Owner – creation, maintenance, and distribution of CMC documents
• Managed Quality Assurance paper archive
• Lead harmonization efforts for cross-functional internal procedures

Certificate, Comprehensive Project Management

M.S., Regulatory Affairs And Healthcare Policy

B.S., Pharmaceutical And Healthcare Business