Daniel Comstock Email and Phone Number

Responsible for QA activities/decision making associated with cGMP manufacturing, investigations, change controls, complaint investigations and documentation. Assists in ensuring proper controls are institued and maintained during manufacturing, processing, packing and warehousing of product.

• Manage staff, conduct performance reviews• Assist in the execution of QA systems to support lot release, auditing and training• Review method and process reports for compliance• Review and approve master batch records• Observe manufacturing activities to support implementation of best practices and improvements.• Administer, review, follow-up and approve Deviations and CAPAs (Corrective and Preventive Action)• Write, review and approve SOPs, batch records, material specs. and test records.• Trend and report QA related information (Deviations, CAPA, etc.)• Coordinate or Support IMPD/IND for various product submissions • Perform manufacturing batch record, test record and data forms review.• Review and approve protocols (Manufacturing, Test Method, Equipment (IQ, OQ, and Process Validation, Cleaning Validation, etc.)• QA Lead on Lead Products working with both internal and external Manufacturers (CMOs)• Responsible for performing external audits and CMO site visits as needed• Conduct audits (Internal, Vendors, Suppliers, Sub-Contractors Testing Facilities, and Clinical) when needed• Prepare routine updates and project status report of Quality Assurance activities.• May assist departments with investigations related to manufactured products • Responsible for overseeing the performance of all of the above by direct reports

• Assist in the execution of QA systems to support lot release, auditing and training.• Review and approve master batch records.• Observe manufacturing activities to support implementation of best practices and improvements.• Review method and process reports for compliance.• Administer, review, follow-up and approve Deviations and CAPAs (Corrective and Preventive Action). • Write, review and approve SOPs, batch records, material specs. and test records.• Trend and report QA related information (Deviations, CAPA, etc.).• Perform manufacturing batch record, test record and data forms review.• Review and approve protocols (Manufacturing, Test Method, Equipment (IQ, OQ, and Process Validation, Cleaning Validation, etc.).• Conduct audits (Internal, Vendors, Suppliers, Sub-Contractors Testing Facilities, and Clinical).• Prepare routine updates and project status report of Quality Assurance activities.• Assist departments with investigations related to manufactured products as applicable.

• Executes QA Operations in change control, document control, deviation management, CAPA, batch record review, and lot release.• Performs routine walkthroughs of the Manufacturing areas to ensure that the production and operations areas are in a compliant state. • Provides support during regulatory inspections (FDA, EMA etc.) as necessary. • Responsible for the review and approval of various validation protocols and reports.• Reviews Alexion and contract manufacturing organization (CMO) batch records, SOPs, and other documents.• Approves and closes deviations, document changes, CAPA’s and change orders in compliance with Alexion SOPs and applicable regulatory requirements.• Provides GMP training to staff and contractors as needed.• Supports the internal auditing program as necessary.• Develops, reviews and revises current SOPs for QA operations as necessary.• Evaluates and directs the resolution of quality issues by developing effective interdepartmental and cross-functional partnerships.• Evaluates and provides input into the development of Quality Systems at Alexion.• Establishes collaborative working relationships with other staff in Operations.• Identifies quality issues and communicate to manager as appropriate.• Serves as a Quality representative on cross-functional and multi-site teams as required.• Maintains or supports a variety of short-term projects as related to QA Operations.• Supports Clinical and Commercial Manufacturing operations.

• Responsible for Quality Systems such as deviations, investigations, CAPAs, change controls and complaints.• Responsible for the review and approval of various validation protocols and reports.• Involved in internal audit functions, document creation and review, and data analysis review.• Review and approve internal manufacturing Batch Production Records.• Provide training on various QA Compliance Systems.• Review and Approve Environmental Monitoring (EM) Excursions.• Generate Management Review Metrics.• Supports or maintains a variety of short-term projects as needed.• Provides support during regulatory inspections.

• Responsible for the review and approval of manufacturing and laboratory discrepancies in support of lot release at Acambis manufacturing facility.• Responsible for facility oriented Quality Investigations and Corrective Actions.• Represent Quality Assurance on cGMP compliance issues.• Maintain Deviation/Investigation history database.• Provide leadership on internal audit teams.• Work on complex projects where analysis requires evaluation of identifiable and intangible variables.• Support Annual Product Review.• Review and Approve internal and contract manufacturing Master Batch Records.• Support release of raw materials and final product.• Review and approve critical documentation such as Validation Protocols and Product Specifications.• Schedule/Coordinate Internal Audit Program.• Lead Auditor for Internal and External Audits• Provide training on various QA Compliance Systems.• Generate Management Review Metrics.• Participate in FDA audits.• Support all phases of production from Pre-Clinical to Phase III.• Person in Plant at various contract manufacturers for oversight and release of product.• Project Lead for various product lines as needed.• Interview candidates for various QA positions.• Support process Change Control and Material Review Board Systems.• Review and Approve Environmental Monitoring (EM) Excursions and coordinate EM Meetings as needed.• Participate in the Validation of the ERP System implemented at Acambis.• Support BLA Submissions to FDA as needed.

• Responsible for managing and optimizing the Purification processes for viral vaccines. • Directs daily work of the technicians, all purification activities, solution/media preparation, and maintenance needs. • Makes detailed observations, analyses data, interprets results, and prepares all related documentation.• Works with Associate Director of Viral Manufacturing and the Manager of Materials Management to prepare and meet production schedules.• Exercises technical discretion in the design, execution, and interpretation of purification processes.• Ensures that department is operating to cGMP.• Prepares and reviews all Batch Records, Logs, data associated with each purification batch.• Assists in all validation requirements.• Maintains high level of professional expertise through familiarity with all equipment and purification process. • Contributes to Manufacturing Unit in a team approach to solving daily problems.