Daniel Schuette Email & Phone Number

Marlborough, Massachusetts, Us

• Directed the computer System Validation and IT Quality approach to the validation of a new eQMS combining 7 companies into a single eQMS platform.• Directed harmonizing all former affiliates' Computer System Validation processes into a single set of procedures. Established a philosophy of Computer Software Assurance to right size validation approaches on appropriate application types based on Risk.• Directing the migration approach to migrating all former affiliates data into the new Single eQMS.• Compliance owner for global systems used across our parent company and subsidiaries.• Leading a remote team of 6 people across the US.• Leading a team supporting all GxP applications and systems interfacing with manufacturing facilities.

Cambridge, Massachusetts, Us

Sumitomo Dainippon Pharma Oncology, Inc. was formed through the merger of Tolero Pharmaceuticals, Inc. and Boston Biomedical, Inc. I previously worked at Boston Biomedical, Inc. one of the predecessor companies.

IT Compliance Consultant, Client Boston Biomedical Inc (BBI). May 2019 - Present• Develop and maintain compliance of BBI IT systems to the relevant GxP standards e.g. 21 CFR Part 11, EU GMP Annex 11 and GAMP 5. To assure controls and testing meet industry regulations and systems are fit for purpose. • Ensuring IT systems are monitored for changes and vendors are assessed, so as to assure BBI Data is secure and controlled.• Develop and revise procedures regarding System Impact Assessment and Maintaining the System Inventory.

Tokyo, Jp

Began Employment with Shire Inc.Providing QA oversight of System implementations to ensure data integrity and regulatory compliance is built into our validations. Working with cross functional teams to assist with compliance gap closure.I guide teams using risk assessments to build testing strategies and validation approaches that focus testing on critical risk areas and reduce testing in areas of low risk and leverage other mitigation strategies to create an efficient validation effort. This ensures we meet project timeline while balancing product and patient safety risks and regulatory compliance risks.Key Projects and Systems as Information Systems Quality Lead:• Clinical Supplies Management Database, Upgrade and Process Integration• Trackwise Consolidation Project, Iterating 3 Trackwise instances with duplicate process workflows.• Risk Evaluation and Mitigating Strategies (REMS), Online Physician Certification and Registration Portal.• Implementation of SAP Fiori, to implement scanning solution using iPhones for warehouse material transfers.• 2 Data Centers migration and consolidations into a Colocation facility.Key Highlights:• Authored position statement on the use of Handwritten Signatures executed to electronic records.• Authored the response to FDA for the question regarding the use of Electronic Signatures Executed to Electronic Records as applied to the Risk Evaluation and Mitigation Strategies. This resulted in acceptance on the REMS program.• Lead the gathering and reporting of department metrics including the following areas:o Deviations/Eventso CAPAo Trainingo Periodic Reviewso Audit Schedulingo Quality Agreement Complianceo Change controls• Auditso Co-lead Site audit of colocation facilityo Lead audit for Systecho Supported Audit for ServiceNow.o Lead internal audit for audit for Plasma Shipping and Transfer System

Southborough, Ma, Us

Shire, Lexington MA, Validation Engineer March 2014 – June 2015• Process Data Analytics System • Review IT infrastructure commissioning/qualification of Validation (VAL) and Production (PROD) servers as part of the system validation • Developed Qualification Protocol for data migration tool • Collaborating with PDA system owner in development of pre data migration data clean-up and verification protocol (which feeds into the Data Migration Protocol; IOQ execution verifies that the functionality operates as expected for the migration of historical data files into the Statistica system) • Incorporating ANSI/ASQz1.4 standard and corporate Technical Document for acceptance and rejection of historical data sets • Creating Requirements Trace Matrix (RTM) to document validation progression against original URS • Phase II document preparation includes: validation protocols and summary reports for each IOQ step and PQ, discrepancy resolution, final validation reports.Validation Engineer for automation changes, developing validation plans and qualification protocols for automation changes for Bioreactor process steps and CIP changes including spray-ball test using riboflavin visual inspection method.Supported CAPA investigations and resolutions regarding areas impacting the automation systems including the Building Management Systems.

Paris, France, Fr

• Developed protocol for ERES evaluation of End User Applications to support audit findings around spreadsheets used for GXP decision making.• Coordinated with Genzyme Corporate to assess gaps between site procedures and corporate standards • Created End User Application control awareness marketing with site corporate communications.• Supported audit preparation and responses with End User Application owners in audit ready room.

Boston, Ma, Us

• Developed and delivered Part 11, Computer System Validation practices training to over 200 participants covering GAMP, Part 11 and other relevant standards. • Quality and Validation Oversight Lead• Reviewed System Change Controls for validation and compliance impact. • Ensured systems remained in validated state, working with Systems Owners, Technical Leads and Test Leads to assess system changes and impact to requirements, testing, documentation and regulatory compliance.• Worked with System owners, Test Leads and Technical to define the Validation Plans, Lead Requirements Gathering Workshops with Systems Owners and End Users.• Reviewed test plans and scripts to ensure fulfillment of requirements, and traceability• Final Approver for system URS, FRS, Validation Documentation including validation plans, summary reports, trace matrix, risk assessments, configuration and design specs and system operation procedures (SOPs)• Supported vendor audits for compliance and validation gaps • Quality and Validation Oversight for the following systems and areas. QUMAS Documentation Management System IT Change Management System (MKS) Waters Empower S-Cubed, Regulatory Submission Suite Flu and HCV DNA Sequence Databases (ColdFusion, In House Application) IT Infrastructure Lab Systems• With GIS Infrastructure developed reusable infrastructure qualification process, allowing a streamline of similar technology commissioning. • Co-Quality Lead on Global WAN upgrade and Data Center Consolidation and Migration Coordinated with additional Quality Lead, the planning, qualification and commissioning oversight. Assisted in Collocation Audit.• Developed Small Systems Using MS Access Databases for department metrics tracking and resource allocation planning Test Error tracking, to identify trends in testing error types.

Redesigned IQ/OQ to allow faster and more accurate execution of the test scripts.Coordinated with client sites to discuss test customization.Performed method development/validation, implementation, and PQ design including ASTM E1840 vs. Raw Data peak comparison support with customers via remote and onsite consultation.Received multiple instance of feedback from customers stating the value of my input in PQ design and method development support.Certified 5 international distributors in the IQ/OQ process and good documentation practices in line with CFR 21.Continued multiple customer interactions and work load while performing 80% travel.Lead redesign of IQ/OQ for release of software version 1.2.1.

Boston, Ma, Us

Managed CMC documents such as analytical methods, validation protocols, manufacturing reports and master batch records through the change management process.Developed and implemented Microsoft Access databases for:-QA documentation group to manage glossary terms for global SOPs/work instructions.-QA IS validation group for the capture of metrics for productivity by project and validation/implementation phase. Instructed users on basic SQL concepts enabling custom report generation.- Interface with the Oracle back-end tables of PleaseReview™ enabling metrics around review turnaround time.Created training materials and lead trainings onsite and remotely to MA, UK and CA site through Webex.Executed various software validation scripts to support QUMAS software upgrades.Lead draft meetings for the change management procedure draft engaging impacted departments i.e. Supply Chain, Formulation, Chemical Development, Analytical Development and Quality Control.

Bachelors Of Applied Science, Management Studies

As, Computer Information Systems

Education record