• Responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, CSV procedures, and Data Integrity requirements.• Provide oversight of validation and qualification activities, review and approve validation documentation, risk assessments, work with project teams to determine elements to be validated, conduct impact assessments of proposed changes to computerized systems. • Ensure that Novavax GxP Systems are inspection-ready, in a validated state, and maintain data integrity. Support inspections and audits of Novavax systems.• Key projects include qualification of the Novavax infrastructure in alignment with Annex 11 and overhauling the change management and validation processes to follow a CSA based approach.

Provide QA and QA-IT consulting services to life sciences companies, including: • Audit and Inspection Services - IT Vendor Audits, GMP audits, Quality Management Systems Audits, Supplier Qualification / Re-Qualification Audits.• Computer Software Assurance (CSA) and Computer Systems Validation (CSV) oversight, advisement, and execution of lean, risk based GXP systems validation• Quality Management System Oversight, Gap Analysis and Process Improvement: Risk Management, Deviation and CAPA management.• Develop high quality policies, procedures, and work instructions in alignment with FDA regulations and current best practices (cGMP, cGLP, cGDP, cGVP)• Author QA-related articles, white papers, and training materials. Develop and deliver training. Provide mentoring.

• Gather and analyze information to monitor the current regulatory climate and predict trends. • Author white papers, blogs, and articles on current industry best practices in validation, risk management and other topics. • Developed and implemented Sware Quality Startup Program (for clients needing QA advisement):• Authored SOP library offered to clients. Developed SOP pricing and distribution plan.• Provided guidance for SOP program execution, advised customers on interpretation and usage of the documents. • Developed internal training including, but not limited to, education in GxP, 21 CFR Part 11, Annex 11, 21 CFR Part 820, CSV, CSA, GAMP5, Data Integrity, Risk Management; and Supplier-related Quality activities including Assessment, Qualification and Management.

• Built Sware’s Quality Roadmaps in collaboration with the Quality Assurance Director.• Developed and executed training including, but not limited to, education on GxP, 21 CFR Part 11, Annex 11, CSA, GAMP5, and other relevant topics. • Provided guidance for audit and inspection readiness; advised on audits of Sware by prospective and existing clients across the Life Sciences industry.• Provided independent review, risk management guidance, and quality advisement for internal and external system implementations, computer systems validation (CSV), computer systems assurance (CSA), change management, and data integrity in collaboration with a global cross-functional team.

• Provided quality oversight for key global GxP computer systems, including drug safety (case intake, processing, reporting), clinical trials supply management, clinical data management, and biostatistics/data analysis systems. • Key innovator in the improvement of IT Quality Systems and business processes. • Pivoted Jazz off paper-based computer validation protocols to paperless at the beginning of the pandemic; enabling business continuity of key CSV projects while maintaining a risk-based, streamlined, 21 CFR Part 11 compliant workflow.• Provided independent review and quality advisement for GxP systems implementations, risk assessment, computer systems validation, change management, and data integrity in collaboration with a large, globally distributed, cross-functional team.• Supported the GxP systems validation lifecycle, including review and approval of Validation/Qualification Plans, User Requirement Specifications, Traceability Matrix, Validation (IQ, OQ, PQ, UAT), Data Migration, Periodic Review, Change Control, Deviation, CAPA, and System Retirement deliverables.• Developed and maintained SOPs and best practices related to GxP, CSV, and Data Integrity. • Authored and executed training: Data Integrity, CSV, and GxP.• Led internal and external audits, specializing in IT systems vendors. • Member of the Jazz Global cross-functional vendor oversight and audits team, which developed strategies for and advised on R&D, IT, and Clinical vendor audits. Developed remote audit best practices during COVID, to maintain business continuity.• Leader and volunteer for employee engagement activities including health/well-being (Stanford Blood Drive), community outreach, and philanthropy.• Received Jazz’s Ensemble Award for teamwork, as well as peer awards for leadership, engagement, and collaboration.

• Specialize in documentation for biotechnology, pharmaceutical, LIMS and life sciences companies, including complete implementation of corporate Quality Management Systems for GMP and CLIA organizations; implementation of Software Quality Management Systems including SDLC; performing and resourcing validation of Software as a Service (SaaS) and Platform as a Service (PaaS) systems, with a focus on Salesforce-based systems.• Unique focus on GMP training and education; setting up and validating document management and quality management systems, and HIPAA- and GDPR- compliance and preparedness.• Provide audit and advisory services for HIPAA, Software Quality Assurance, Computer System Validation, FDA compliance, CLIA, Agile Software Project Management for Regulated Environments, and GAMP5 Risk-Based Computer Systems Validation. • Create all types of documentation, including system design specifications, training materials, user manuals, SOPs, on-line help systems and validation tests for commercial and custom-developed software systems, including clinical trials data management systems, safety reporting databases, and FDA medical review systems. Author marketing web content and online help for Apple and Android phone applications.

• Performed gap analysis, design, documentation and roll out of a complete Quality Management System for Third Wave, including the Quality Manual and all supporting standard operating procedures. This also included creation of GDPR and HIPAA policies. • Implement a system for document control, training management and change management in collaboration with management team members. • Create and execute validation plans and related test cases for Third Wave’s laboratory information management system (LIMS), which is based on a Force.com engine, for internal-facing development efforts, as well as for customizations to external Third Wave customer systems. Interpret and apply GAMP5 risk-based computer validation processes to ensure continued quality of software updates.• Write knowledge base articles and bi-weekly blogs on product features and quality assurance topics.• Provide QA advisory services to Third Wave LIMS customers to meet applicable regulations and standards including, but not limited to, 21 CFR Part 11 electronic signature and records requirements, 21 CFR Part 820, GMP, ISO 13485, ISO 17025, and CLIA.

• Responsible for Quality Planning, internal and external audits, supplier audits, agreements and assessments.• Managed day-to-day quality assurance activities at MagArray, including management of Document Control, Equipment and Inventory Management employees.• With Technical Supervisor of the CLIA Lab, prepared MagArray to pass its California State CLIA licensure.• Audited MagArray’s HIPAA compliance as part of commercial readiness. Performed gap assessment and risk analysis, and then created documentation to satisfy gaps in compliance. • Worked with Supply Chain Engineers to audit external suppliers, create procedures for managing, handling and inspecting incoming PCBs, document and implement process improvements to the Supply Chain.• Ran Quarterly Management reviews of Quality Systems and Metrics in compliance with 21 CFR Part 820.20. • Ensured that all software systems used in the Lab for commercial sample processing were validated prior to use in production activities; created and ran validation protocols.• Authored Standard Operating Procedures, training presentations, and other documentation to ensure that MagArray’s Quality System complied with 21 CFR Part 820, 21 CFR Part 11, and 42 CFR 493.• Conducted new-hire and refresher training on a variety of topics, including HIPAA, Good Manufacturing Practice, and Good Documentation Practice.

• Managed multiple systems validation projects. Direct supervisory experience for two employees, plus managed cross-functional project teams ranging in size from 3 to 15 people. • Built the Software QA team, hired engineers, and managed the department budget.• Responsible for documenting, validation, and enforcing change control of Agile-developed software systems required for business continuity and CLIA lab compliance, working remotely with teams based in San Diego, CA (USA) and Vancouver, BC (Canada). • Developed GenomeDx’s Software Quality Management System, including the Software Quality Assurance Manual and all supporting SOPS; Software Development and Implementation Lifecycles; 21 CFR Part 11 and 21 CFR Part 820 compliant Software Validation and Verification Procedures, and Risk Assessment and Risk Management SOPs in alignment with GAMP 5. • Held a central role in the implementation of VeevaVault QualityDocs. As System Owner, was responsible for initial validation, as well as ongoing risk evaluation and change management activities for Vault upgrades. Maintained Vault-related procedures, managed documents for the Software Engineering group, and assigned/tracked training. • Developed and executed validation plans for Software as a Service (SaaS) systems. Authored software validation life cycle documentation (including design history, test plan, test cases and reporting) for GenomeDx’s Accessioning and Reporting System and GenomeDx’s internally developed Salesforce-based LIMS. • Authored documentation, training presentations and project plans to ensure compliance with standards including 21 CFR Part 11, 21 CFR Part 820, HIPAA, ISO 13485, and Clinical Laboratory Improvement Amendments (CLIA). Provided training across the organization.• Acted as Software QA SME during GenomeDx’s CLIA and CAP accreditation audits.• Key member and facilitator of Software Engineering Review Board.

• Responsible for Document Control and daily QA department activities. Presented and documented new hire, safety, GMP, HIPAA, and Quality Systems training.• Collaborated with a consultant to plan a new document classification system, and update documentation for the company’s QMS, including the Quality Manual, Standard Operating Procedures, Forms, Work Instructions, in compliance with 21 CFR Part 820, ISO 13485, and Clinical Laboratory Improvement Amendments (CLIA) Part 493, Subpart K - Quality Systems for Non-Waived Testing.

Managed software implementation, upgrade and validation projects for both internally developed and purchased applications. Collaborated in all project phases, from development of project specifications and budget, development, testing and validation, as well as post-implementation planning.Managed system validation projects, created test plans and scripts in compliance with CFR 21 Part 11.

Started with ALZA as a consultant in 1995, then hired by ALZA full time as a Senior Technical Writer in 1998, then promoted to IT Project Manager in 1999• Project management of company-wide software implementations for a corporate user base exceeding 2200 users.• Created system documentation, training materials, manuals, SOPs, on-line help, websites and test cases.• Managed documentation and software implementation projects. Analyzed project budgets and timelines, as well as staffing requirements.

Founded Clarity, marketed and located clients. Worked with clients (including ALZA Corporation) to ascertain and fulfill their training, technical writing and systems design-related needs. Projects included:Created user documentation, system design specifications, training materials, SOPs, on-line help systems and validation tests for commercial and custom-developed software systems, including clinical trials data management systems, safety reporting databases, and FDA medical review systems. Provided on-site training.Drafted systems development operating procedures and documentation standards to bring clients into GMP/cGMP compliance and ISO 9000 certification. Participated in software validation project management and software validation testing.; Developed commercial course materials and manuals for business application software. Provided copy writing services for marketing materials and software packaging.Project management of major software upgrades, including coordination and supervision of installation, testing, documentation and training efforts.Clients included: ALZA Corporation, Sierra Scientific Software, CTE Computer Training, and Academix Software.