Amy Morse Email & Phone Number

Orlando, Fl, Us

• 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.• Work with key stakeholders to assure resolution of compliance issues.• Assure compliance to Quality Technical Agreements• Identify, communicate, and review Quality issues, develop solution proposals and participate in investigations as appropriate.• Ensure appropriate escalation of quality events.• Support the continuous improvement objectives involving the Quality organization.• Participate in inspection related activities, gap assessments, and response/mitigation activities.• Participates in collation of metrics to evaluate quality performance of CSP or Strategic Business Partner

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• Collaborate with CMOs in quality agreement revisions, process improvement projects, production activities, validations and inspection support• CMC document and SOP creation, maintenance, and approval in electronic document management system• Partner with Vendor Management and Audit teams to assess and track CMO performance• SME for continuous improvement efforts including robotic process automation application, Veeva workflow validation, and reduced review efficiency efforts• New hire training SME and mentor in Vertex internship programs

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