Michael Joos Email & Phone Number

Wilmington, De, Us

Durham, North Carolina, Us

Chadds Ford, Pennsylvania, Us

Assigned to pharmaceutical industry customers as a Computer Systems Validation, and/or Information Technology Quality Consultant.June 2023 - Present:Assigned to Cronos Clinical Consulting Services, Inc. in Lambertville, NJ; a subsidiary of IQVIA.Re-validation of the Cronos Integrated Research Platform, an electronic clinical outcome assessments (eCOA) system, and other legacy Cronos software tools in accordance with IQVIA system development lifecycle procedures.Integration of Cronos policies and procedures into IQVIA’s Quality Management System. December 2021 - June 2023:Assigned to the Center of Breakthrough Medicines in King of Prussia, PA; a contract manufacturing organization.Led the validation and implementation of the ValGenesis electronic Validation Lifecycle Management System.System Administrated ValGenesis, trained new users, and served as primary contact for system related issues.Transitioned to an IT Quality Compliance and Computer Systems Validation Lead role, assisting with the validation of the Empower Lab Management System, and LabWare Laboratory Information Management System. While also authoring process improvements, deviations, change management, and continuous improvement projects.

Wilmington, Delaware, Us

Served as the Global Quality, eSystems representative for regulatory inspections, explaining procedures and presenting validation deliverables, with zero computer systems validation inspection observations during my tenure.Led continuous process improvements, such as implementing the computer software assurance (CSA) approach to user acceptance testing, and a GAMP compliant risk-based approach to validation.Managed the Computer Systems Validation Audit Program.Conducted Computer Systems Validation Audits of information technology application vendors and service providers.Served as the Quality Assurance lead on computer system validation projects, providing guidance on procedure and regulatory expectation adherence.

Wilmington, Delaware, Us

Ensured Incyte’s state of inspection readiness by maintaining the validated status of computerized systems used across the drug development lifecycle, and other regulated activities.Negotiated and persuaded business area stakeholders of the need to validate computer systems by identifying applicable predicate rules, explaining regulatory expectations, and strategizing a risk-based approach. Project managed the validation of regulated computer systems across various business areas, including Discovery, Toxicology, Clinical Development, Regulatory Affairs, Pharmacovigilance, and Medical Affairs.Validation and Test Lead for Veeva Clinical Trial Management System (CTMS), Veeva electronic Trial Master File (eTMF), Veeva Study StartUp, Veeva Quality Management System (QMS), and Veeva Document Management System (VeevaDocs).Authored computer systems validation documentation; Regulatory Assessment Form, Validation Plan, User Requirements Specification, Test Protocol, IQ Test Scripts, User Acceptance Test Scripts, Production Test Scripts, Test Summary Report, and Validation Summary Report.Served as Business Analyst by attending business area meetings, vendor demonstrations and workshops, to identify and formulate business user requirements.

Cambridge, Cambridgeshire, Gb

Implemented three simultaneous computer system upgrades across two patient safety reporting systems, within a very tight timeframe. Organized the collection of user requirements, authored the User Requirements Specification, and orchestrated project team meetings to ensure stakeholder awareness, managed test script writing and execution of user acceptance testing. Served as both the Patient Safety business area representative and validation lead for the development of a TrackWise based Corrective Action / Preventative Action (CAPA) application. Project managed the creation of all validation deliverables, trained and managed test script writers and those that executed test scripts.Ensured compliance with global and local patient safety reporting objectives, policies and processes.Managed the Safety Agreement relationship with External Licensing Partners of AstraZeneca products.Negotiated corrective actions and preventative actions with external licensing partners, and internal business area partners, for late adverse event case reports.

Cambridge, Cambridgeshire, Gb

Served as the CSV Regulatory Inspection Readiness Team Lead for domestic and global regulatory inspections. As a Clinical Development Computer Systems Validation Subject Matter Expert, provided response to queries from regulatory agencies regarding computerized systems used in the conduct of AstraZeneca clinical investigations.Planned, conducted and reported internal and external computer systems validation and GCP audits of systems deployed at global AstraZeneca R&D Sites, marketing companies and vendors. Audited software vendors, data center services, Contract Research Organizations, Academic Research Organizations, clinical laboratories, clinical pharmacology units, and electronic data-capture vendors (eCRF, electrocardiogram analysis, medical image analysis, electronic patient reported outcome and IVR/IWR type systems). Domestic and International auditing experience (US, Europe, India and Japan). Provided guidance to internal clients and vendors, ensuring recommended corrective actions to audit observations receive appropriate response. Collaborated with internal business areas in resolving regulatory compliance issues, and contributed to the development of audit programs to ensure fulfillment of global Clinical Quality Management process improvements.

Cambridge, Cambridgeshire, Gb

Managed the computer systems validation efforts for local and global Drug Development Information Systems project teams. Oversaw and contributed to the creation and review of computer systems validation documentation, assuring compliance to AstraZeneca local and global requirements, and regulatory expectations. Contributed to numerous Process Improvement Programs including updates to system development life cycle processes and the creation of a global project management life cycle.

Certificate, Quality Assurance & Regulatory Affairs

Bs, Applied Mathematics