October 2023 to present: Kephera Diagnostics, Framingham, MAManager, Quality Assurance• Develop and Implement Quality Management Systems to comply with Medical Device Regulations 21 CFR 820, and CLIA test laboratory regulations. • Manage QA processes, including document control, supplier quality, internal audits, continuous improvement and training.• Oversee quality activities related to GMP materials, production, laboratory, facilities, and equipment.• Review documentation related to GMP manufacturing and CLIA testing.• Ensure compliance with documented policies and procedures.• Support the authoring and submission of regulatory filings.• Support regulatory inspections.• Along with the CLIA Lab Director and leadership, maintain laboratory audit readiness by overseeing and managing clinical lab audits with regulators, pharmaceutical partners, and with other agencies, ensuring that internal system and process audits are scheduled and conducted.• Lead the CLIA Quality Management Program to maintain and improve a QMS that is compliant with the applicable regulations and standards.

• Quality Lead for two clinical drug products for the organization to include:• Quality Contact for multiple Contract Manufacturing organizations for batch production, testing, product stability, deviations, change controls, external auditing, and weekly CMO team meetings.• Batch Review and Release of Spray-dried intermediate drug product through• through Bulk Drug Product, primary packaged Drug Product and labeled finished goods including:o Master batch record and executed batch record review, approval communication with CMO program management, and archiving of documentation in the Veeva QMS system.o Deviation assessment, review and approval using the Veeva QMS system.o Change control assessment, review and approval; Veeva QMS system.o Product Test Specification and CoA review and approvalo Review of CMO Quality Agreements for alignment with internal requirements, changes and updates• SOP/Procedure development, review, approval and training• Quality Representative to Drug Program Management weekly meetings to provide updates on release timelines, deviation and change control closure timelines, and work with supply chain management on shipping and distribution scheduling.• Participation in QA departmental continuous improvement initiatives including streamlining Veeva workflows and processes for batch release, external CMO deviation management, product shipment temperature excursion management

• Managed and executed the review, approval and release of clinical trial drug products • Review and approval of drug product master batch records and executed batch records for bulk drug product manufacturing and primary packaging.• Change control management, review, approval and closure• Primary contact with Contract Manufacturing Organizations (CMO,) Project Management teams and Quality Assurance teams• Primary contact with internal Supply Chain teams for product release and distribution scheduling• Represented Quality Assurance on project team meetings to provide GMP guidance on change control requirements, batch review and release timelines, and clinical product expiry extension requirements• Responsible for clinical trial product deviation reviews root cause analysis, corrective and preventive actions, product impact assessment, trend analysis, approval and closure

• Managed and executed the review, approval and release of six clinical trial drug products• Active Pharmaceutical Ingredient (API) master and executed batch records • Drug Product master and executed batch records for primary packaging, final packaging, kitting and labeling• Deviation assessment, review and approval• Change order/Change control review and approval• QP release support for European Union (EU) distribution• Labeling review and approval for multiple countries• Primary contact with contract manufacturing organizations’ (CMO) Project Management teams and Quality Assurance teams• Primary contact with internal Supply Chain teams for product production scheduling, product release and distribution scheduling• Manage clinical trial product complaints system• Prepare and present monthly Quality Metrics to senior management• Quality Assurance representative to the site team implementing TrackWise systems (electronic deviations and product complaints databases) including internal change control requirements, computer system validation (CSV) support, and training of site personnel on system use and requirements • Responsible for clinical trial product deviations, manufacturing investigations, root cause analysis, corrective and preventive actions, product impact assessments, trend analysis and closure• Lead Auditor on Contract Manufacturing Organization (CMO) auditing and vendor/supplier auditing

• Managed direct reports/associate level staff for Quality Assurance product release responsibilities• Managed and executed batch release to meet project timelines and customer commitments• Managed review and disposition of raw materials and manufacturing components, issuance of Quality release documentation and product certificates of analysis• Managed and executed product intermediate (bulk drug substance and bulk drug product) review and release including batch record closure, QC test result review, deviation and change control closure• Performed cGMP auditing of external vendors, suppliers and contract manufacturing organizations (CMO) and contract test laboratories• Supported Compliance activities through execution of the following systems: • Deviation investigations, CAPA resolution and closure• Change Control review and closure• Review of IQ/OQ/PQ Validation protocols and reports for process validation, equipment validation, cleaning validation, QC test method validation• Product Complaints Officer for the site• Investigation leader for product complaint driven Manufacturing Investigations• Monitoring, tracking, reporting Quality metrics for continuous improvement• Participate in FDA inspections including:• Training staff on inspection procedures and guidance• Subject matter expert on QA release systems, batch record review, Product Complaint handling, Raw Materials systems• 483 Response development, execution and closure

Supervisor, Quality Assurance; Product Quality• Supervise QA Associate level staff responsible for Product Release systems including review of Batch Production Records, QC test results, Environmental Monitoring data and Deviation closure• Oversee CMO/Person-in-plant QA responsibilities including role development, immediate action and communication responsibilities, real-time batch review, deviation resolution• Manage Raw Materials review and release systems including QC test results review and electronic inventory management system (SAP) operations• Manage the Material Review Board function• Ensure timely lot release to meet project timelines, and customer commitments• Continuous improvement initiatives:• Reduce lot release cycle times• Conduct training/guidance sessions to improve compliance with QA and Manufacturing procedures and systems• Improve lot release data capture and metrics reporting• Support Compliance related activities through execution of the following systems: • Deviation resolution and closure• External CMO, Test Lab and Vendor auditing• Internal cGMP Auditing• Participate in FDA inspections including:• FDA Inspector escort and scribe responsibilities• SME responsibilities for QA Release systems• 483 Response teamAug. 2001 to Acambis, Inc July 2007 Canton, MaAssociate II, III, IV, Quality Assurance • Co-develop and implement product release systems including review of manufacturing batch records, media and solution prep. records, QC results, contract manufacturer (CMO) records and deviations • Develop, review and revise QA and manufacturing documentation in support of the above functions • Develop product labeling materials • Prepare and issue product CoAs • Internal cGMP auditing and vendor and contractor auditing • Review and release of raw materials • Operate quality systems including deviation reporting and investigations