KATINA Allen

• Responsible for supporting the Global R&D organization from a technical and business process perspective
• Responsible for the implementation of new R&D software applications, projects and the administration of existing applications and processes
• Provide compliance oversight with respect to R&D e-system usage requirements
• Assist in the creation of validation test scripts and provide direction to staff on the execution of UAT testing and other validation deliverables
• Collect user requirements and operationalize complex processes
• Maintain user permissions and perform regular user access verifications
• Prioritize, resolve issues, and implement changes which may include contracting with external vendors
• Organize and prepare training sessions for all global R&D staff
• Develop training materials for end-user training sessions
• Deliver training through instructor led (in-person and/or online) trainings

• Manage Global Ax R&D Training program
• Manage training assignments and associated training documentation and inquiries
• Provide strategic leadership and support for R&D Quality activities related to Global electronic Quality Management System (eQMS)
• Conduct Master Control (eQMS) overview for all Ax R&D EU new hires
• Support Ax R&D related Issue Management (e.g., NCRs, CAPAs, Deviations and change requests)
• Assist in ensuring applicability of current quality policies, procedures, and objectives by keeping informed of the latest updates related to applicable regulations
• Liaison for procedural document management and training activities for Global R&D functions and the Quality Operations department to assure QMS strategic alignment and compliance
• Effectively manage procedural documents as defined by the QMS, R&D department, R&D project teams, and overall corporate objectives
• Provide support in the harmonization of QMS initiatives within the R&D group
• Provide project support to improve R&D compliance and operational efficiencies
• Support R&D related audits, both internal and external
• Support R&D vendors/supplier’s qualifications
• Support all company regulatory authority inspections and certification body audits, as applicable
• Provide support to the overall business and company-wide objectives
• Adhere to CFR 21 (Parts 210/211/820) along with ISO 13485 and ISO14971

• Responsible for the oversight, maintenance, and administration of the Quality Management System (QMS)
• Provide support to all Global Clinical Trial Distribution (CTD) and Logistic Branches of Marken and actively contribute to critical business activities as it relates to Records Management, Issue Resolution, CAPA Processes and Audits
• Responsible for developing and executing effective strategies supporting quality management and compliance systems and processes
• Execute strategies for maintaining electronic quality management systems in a controlled, regulatory environment
• Global Systems Owner that ensures controlled documents are maintained in a compliant manner throughout their life cycle including translations and associated trainings and tests
• Collaborate with process owners to ensure periodic review of procedures and processes are conducted - current and in compliance with applicable global regulations and Marken policies and procedures
• Evaluate and manage continuous Quality process improvements
• Contribute to the identification, development and use of electronic tools and continuous improvements for the administration of quality management systems and clinical trial distribution
• Process Service Now tickets by providing issue resolution for all system related requests
• Establish and manage efficient recordkeeping of controlled documents to ensure that an effective data trail can be maintained as it applies to CFR 21 Parts 11, 210, 211, 803, 820 and ICH Q7
• Oversee and drive the creation of procedures to ensure compliance with global and regulatory standards to support the overall Global Quality Management System (QMS.)
• Interface and establish effective interaction across multiple departments and with internal stakeholders including regional and global teams to drive process improvement
• Provide guidance to personnel as necessary to define and resolve quality issues, deviations, investigations, root cause analysis and CAPAs
• Develop and provide training for processes related to the administration of the electronic quality management system and global regulations
• Manage and mentor global team of Quality Associates to support all Global QMS related activities
• Use prudent independent judgment to balance quality expectations and other stakeholder needs
• Generate Quality Management System metrics and conduct analysis of these metrics monthly
• Manage quarterly Quality Counsel Meeting with Executive Committee
• Assist with internal audits to ensure cGMP, GCP, GDP, GdocP (GxP) compliance with Marken internal procedures and global regulatory requirements

• Provide strategic leadership and functional vision to help support the overall culture of Global Quality Assurance
• Implement team building activities to help increase morale and I&D within the department by utilizing company’s core values
• Work cross-functionally with Production Services, R&D, Marketing, Sales, GEMs, SCLs and larger GQA team to improve quality processes, systems and tools while ensuring compliance with regulatory requirements for BBI OTCs
• Assist with new OTC innovation projects by reviewing and approving validation IQ, OQ and PQ protocols in ILX
• Review and approve new product innovation specifications in Product Lifecycle Management (PLM)
• Monitor RT, accelerated, and annual product stability pulls and KPI reporting
• Manage the day-to-day operations and release approval of finished goods across 3+ OTC external manufacturing and warehouse facilities and DHL
• Approve third party P2P lab invoices in myBUY (Coupa system)
• Perform gap analysis and issue management of operational sub-processes to ensure ongoing health of BBI eQMS
• Provide International support to Asia, Greater China, UK, and Canada by managing eSPACE scorecard data and attending monthly GCDOT
• Manage budget forecast for BBI third party annual product stability testing, Service Level Agreements (SLA) and
• Statement of Work (SOW)
• Manage the annual product review process by working closely with external manufacturing and supplier facilities
• Member of GQA sub-I&D committee, BELIEVE and Mental Health Champions ERG
• Manage nonconformance, complaint investigations, management of change, CAPA, supplier quality and audits as the
• Intelex eQMS system admin for BBI

• Oversaw domestic and international complaint handling process for the entire enterprise by reviewing, monitoring, and assessing complaints to identify manufacturer and supplier quality issues
• Collaborated with Global Insights and the Consumer Affairs team to effectively manage international safety escalations
• Conducted risk analysis and served as CAPA coordinator
• Managed product lot release
• Organized the coordination of Annual Product Reviews at external GxP manufacturing facilities
• Managed Internal Audits
• Adhered to Code of Federal Regulations Title 21 (21 CFR Part 11; 210, 211 and 820)

• Managed control documents
• Supported BBI lot release program by verifying product master list, corresponding bulk and finished good certificate of analysis and micro test data
• Utilized product data management system (PDM) and SAP as appropriate
• Assisted with the implementation of the Burt’s Bees Internal Audit (IAP) schedule
• Managed Success Factors myLearning platform as training coordinator for all Corporate staff

• Managed customer/consumer complaints and adverse events
• Performed data reviews and assigned investigations as warranted
• Conducted risk assessments and opened deviations as appropriate
• Provided Global customer support for Certificate of Analysis and Compliance (COA/COC) including Customs Quality Certificate requests for Argentina

• Collected and analyzed quantitative/qualitative data to ensure accurate client representation
• Maintained high empathetic client relationships; built rapport while delivering exceptional quality services
• Managed multiple projects simultaneously with strong attention to detail
• Exhibited effective management skills to ensure that all statistical, scientific operations and practical procedures were successfully met
• Adhered to client and project specific protocols by utilizing effective training methods for direct reports

• Administered social scientific research studies using a computer assisted telephone interviewing system for the Centers for Disease Control and Prevention (CDC), Department of Education (DOE) and Department of Justice (DOJ)
• Collected and recorded research data to accurately represent human study sample nationwide
• Maintained efficiency by adhering to project specific protocols