Ruby D.

• Lead day-to-day administration of Quality Systems (EDMS, LMS, eQMS), ensuring stable operations, data integrity, and ongoing regulatory compliance. • Own the full document control program, managing document creation, formatting, metadata assignment, review and approval workflows, controlled issuance, version control, periodic review, and archival in accordance with GDP and regulatory expectations. • Partner with SMEs and business owners to design document structures, naming conventions, templates, and lifecycle states that support efficient authoring and inspection readiness. • Establish and maintain training programs by building curricula, defining role-based learning paths, and aligning training assignments with job responsibilities and GxP impact. • Monitor training completion, manage overdue escalations, generate compliance metrics, and provide management reporting to demonstrate training effectiveness and inspection readiness. • Administer user accounts, roles, and permissions, ensuring appropriate access control, segregation of duties, and data governance across quality platforms. • Develop and maintain dashboards and reports for document status, training compliance, and quality metrics to support audits and regulatory inspections. • Support Computer System Validation (CSV) activities by executing test scripts, documenting results, and maintaining validation traceability for GxP systems. • Deliver end-user training, onboarding, and ongoing support, providing system navigation guidance, troubleshooting, and process coaching. • Author and maintain SOPs, work instructions, and training materials governing document control, training administration, and system use. • Support system enhancements, upgrades, and change requests by providing administrator and business-user input to improve document and training workflows.

• Collaborate with GMP QA Operations, GCP QA, and other functional stakeholders in the development, implementation, management, improvement, and archival/maintenance of Alladapt’s Quality Systems and related infrastructure to ensure compliance with applicable regulations and standards. • Oversee current Quality Systems to support training, document lifecycle, and records retention for GxP functions. •Participate in the evaluation, selection, configuration, qualification, and implementation of the Electronic Document Management System (EDMS) and Learning Management System (LMS) to ensure compliance of these systems with regulatory requirements. Identify and develop procedures for validation. Act as Business Owner for EDMS and LMS. • Provide quality oversight of Alladapt GxP computerized system validation and data integrity program. • Manage and monitor Alladapt GxP change control, internal deviations, and CAPAs. • Perform periodic reviews of Quality Systems for potential gaps, overall effectiveness, and opportunity for continuous process improvement. • Oversee and organize companywide GxP training, including managing GxP curricula, in collaboration with functional management. Ensure appropriate GxP training requirements/plan are defined for all job roles and training records are current. • Support and coordinate internal audits. • Support and coordinate external audits and regulatory inspections (including mock BIMO and PAI) as needed • Coordinate and manage reporting of Quality metrics and overall effectiveness of the Quality Systems for Management Review meeting. • Lead or execute other projects and initiatives assigned by Management or based on company business needs.

I managed the document control program for the QA Department, established metrics and trends to drive customer satisfaction and quality optimizations, oversaw three personnel, and coordinated with cross-functional teams throughout the decision-making processes for document reviews. I also provided guidance to the quality assurance team in coordination with management teams, assigned responsibilities, defined priorities, and ensured alignment with overarching strategic objectives. • Led the implementation of the Veeva QualitySuites (QualityDocs, Training, QMS), which resulted in the transition from a paper-based system to electronic system and enhanced the user experience. • Identified improvements to the QualityDocs system and ensured completion of ongoing re-qualified activities, which streamlined operations and reduced labor costs. • Reviewed and Approved as a Business Owner all Computer System Validation deliverables to ensure alignment with business processes. • Provided support to the IT Department with controlled documents during the migration to Veeva QualityDocs, and created curriculums in Training Vault to increase training completions. • Supported the vendor management program, tracked, identified, and qualified vendors, and coordinated cross-functionally to perform audits. • Served as a Quality Lead for reviewing and approving non-GxP systems and other GxP systems, including DocuSign, SaaS, Veeva Clinical Vault, and Safety. • Coordinated with Department Heads to develop training curriculum for all cGxP and non-cGxP staff.

I managed all aspects of quality system functions for the organization, ensured alignment with business needs, drove talent development activities, and oversaw a team of six personnel. I also served as Owner for all quality processes, including document management, Veeva, QualityDocs, records management, and GxP training management. • Drove ongoing adoption, implementation, and enhancements for Dermira’s Quality Management System and provided leadership to support critical business areas. • Identified continuous improvement opportunities for GxP electronic systems, established stakeholder engagement models, and developed an IT roadmap in coordination with cross-functional teams. • Continuously improved GxP electronic systems owned by Quality: • Identified and developed Business Owners and Business Administrators for quality systems and ensured GxP compliance with business requirements and IT change controllers. • Served as the Business Owner for data integrity, ensured compliance with policy requirements, and supported regulatory inspections for assigned areas

I managed the Center of Excellence team, defined project priorities, developed infrastructure to enable capabilities for quality systems, and led the GxP Business Owner Community to ensure alignment with strategic priorities and integration of the ecosystem. • Identified and developed Business Process Owners and Business Administrators for systems, including ensuring end-to-end process management, master data management, and training. • Defined services and capabilities for the Center of Excellence, drove enhancements to improve the stakeholder experience, and established and communicated KPIs, metrics, and trends. • Served as the Architect to align business needs and drive the integration of GxP systems into core business processes, which included providing thought leadership to the organization. • Partnered with the IT Department to ensure system capabilities are fully leveraged, including data visibility, data analytics capabilities, automation, and data exchange. • Developed a continuous improvement roadmap for all aspects of capabilities with a focus on process optimization, people management, and technology integration.

I defined project scope and deliverables to support business goals in collaboration with senior management and stakeholders, managed project timelines, and coordinated with vendors, IT partners, Quality Assurance, and Validation teams to coordinate implementation activities. • Coordinated with cross-functional teams to develop system requirements, oversaw documentation and design specifications, executed qualification tests, and wrote validation documents. • Managed system operations for Veeva applications, drove change management activities, and oversaw department procedures for the development and maintenance of documentation. • Analyzed user enhancement requests to deliver solutions, improve business processes, address process gaps, drive automation, and enable the growth of the organization.

I served as Business Process Owner for the implementation of electronic management systems Veeva Vault, QualityDocs, and the ComplianceWire learning management system. I also ;ed a team of four GxP Specialisits and managed all aspects of the GxP training program including the distribution of training records, filing of completed records, training compliance, and auditing. • Supported the onboarding of 112 Sales Specialist,14 Division Manager, and Field Training Specialist in preparation of commercialization. • Oversaw the maintenance of GxP related quality systems, SOPs, policies, and manuals, including the routing of new and revised procedures according to established timelines and stakeholder feedback. • Managed external documentation from CROs and CMOs including master batch files and executed batch files, raw data, method validation protocols, release testing data, study protocols and reports.