Emily Kopp Email and Phone Number

• Business Relationship Manager for CARISMA3 Offshore Data Entry Projecto Established and implemented project plano Coach and supervise Global Regulatory Platforms and Delivery (GRPD) Data Analysts to ensure consistent and proficient use of the Audit Management System and processes• Develop strategic business processes and tools to enhance use of CARISMA3 by liaising with CH, R&D, PQPRD, WREF and GQA staff as a Business Analysto Delivered a robust QA program for GSK and improved… Show more • Business Relationship Manager for CARISMA3 Offshore Data Entry Projecto Established and implemented project plano Coach and supervise Global Regulatory Platforms and Delivery (GRPD) Data Analysts to ensure consistent and proficient use of the Audit Management System and processes• Develop strategic business processes and tools to enhance use of CARISMA3 by liaising with CH, R&D, PQPRD, WREF and GQA staff as a Business Analysto Delivered a robust QA program for GSK and improved tracking capabilities of the SQI process by negotiating Clinical QA expectationso Delivered and managed a Business Monitoring program for World Wide Real Estate & Facilities (WREF) to enable their business to effectively and consistently track and manage CAPAs by simplifying tracking methods from 10 systems to 1 harmonized system and process• Liaise with IT resources to develop and implement lifecycle management for CARISMA3, by ensuring compliance and quality with the IT Quality Management System while acting as a key User Administratoro Advise and support CH, R&D, PQPRD, GQA and WREF users across all Business Areas, including associated third-party service providers Design, implement and identify areas of improvement in the system access request process and oversee relevant updates Provide expertise and technical advice on Data / Date changes to ensure they are fit-for-purpose Implement systems, tools and processes used for metrics generation and reporting Analyze and identify specific needs for users across Sites and Business Functions while ensuring processes and systems align with those needs Participate in delivery of quarterly CARISMA3 configuration releases to assure maintenance of an agile platform Monitor, coordinate and implement new processes and tools as a Business Analyst for GQA and R&D through the CARISMA3 change management process Show less

• Liaise with PSC, CH, A&A, PQPRD, WREF, QWF and GQA by interacting with Lead Users and Administrators to identify, develop, and implement potential areas for harmonization and collaboration to ensure alignment across GSK Redesign and refresh the CARISMA3 and GQA Intranet presence for a simplified user experience• Generated and published weekly CARISMA3 metrics to global key stakeholders (approximately 2000 users)o Acted as Change Agent during the transition from weekly metrics… Show more • Liaise with PSC, CH, A&A, PQPRD, WREF, QWF and GQA by interacting with Lead Users and Administrators to identify, develop, and implement potential areas for harmonization and collaboration to ensure alignment across GSK Redesign and refresh the CARISMA3 and GQA Intranet presence for a simplified user experience• Generated and published weekly CARISMA3 metrics to global key stakeholders (approximately 2000 users)o Acted as Change Agent during the transition from weekly metrics reports to the Spotfire Dashboards Show less

Information System Associate , Pharmaceutical Development• North American SOP Administratoro Managed electronic and SOP paper based information system (Documentum Workspace) for North Americao Formatted, published and announced local and regional policies and procedureso Managed, harmonized, and organized implementation of PharmDev SOP system at satellite site in Mississauga, Canadao Generated/issued, distributed, and reconciled official copies of SOP’so Provided… Show more Information System Associate , Pharmaceutical Development• North American SOP Administratoro Managed electronic and SOP paper based information system (Documentum Workspace) for North Americao Formatted, published and announced local and regional policies and procedureso Managed, harmonized, and organized implementation of PharmDev SOP system at satellite site in Mississauga, Canadao Generated/issued, distributed, and reconciled official copies of SOP’so Provided expertise and customer service in support of GMP operations and electronic systems (e.g. SOPMAN, SOPCom, and Templates and Guidance [TAG]) for GMP documentationo Created and updated customer Hints and Tips documents for Pharm Dev systems and processeso Managed North America SOP mailbox on a daily basis providing responses to customer’s with a 24 hour turn around timeo Interfaced with Document Management to archive GMP Procedureso Summarized and reported procedural metrics on a World Wide basis• Served as Methods and Specifications Administrator - formatted and prepared documents; issued and approved documents for all impacted organizations. Managed Global mailbox, providing customer service in support of iMAS (international Methods and Specifications) and templates.• Managed Template and Guidance (TAG) information system for all Pharm Dev sites - Generated local and global templates, published and announced templates to staff, created and updated TAG “Standard Practice” documents Show less

Document Compliance Specialist, Biopharmaceutical Development• Created, revised, and formatted standard operating procedures (SOP), methods, specifications, deviations, and change control documents• Issued and reviewed GMP documents for accuracy• Reconciled and archived controlled forms, media lots, and equipment logbooks• Created and issued Manufacturing and Control Instructions for projects in Biopharmaceutical Development• Reconciled and archived executed batch records… Show more Document Compliance Specialist, Biopharmaceutical Development• Created, revised, and formatted standard operating procedures (SOP), methods, specifications, deviations, and change control documents• Issued and reviewed GMP documents for accuracy• Reconciled and archived controlled forms, media lots, and equipment logbooks• Created and issued Manufacturing and Control Instructions for projects in Biopharmaceutical Development• Reconciled and archived executed batch records and related documentation• Managed the Document Compliance mailbox and delegated appropriate tasks to team members as necessary• Performed all areas of controlled document management and archiving Show less

• Created and established new cataloging system to ensure more efficient access to regulated and controlled documents by users.• Collaborated with scientists to update and revise SOPs and Manuals.• Documented and stored SOPs and Manuals into a catalogued system.• Archived, reconciled and inventoried current and outdated SOPs and Manuals.• Created and maintained procedural layout and spreadsheets using Microsoft Excel and Word.• Provided all aspects of document control and… Show more • Created and established new cataloging system to ensure more efficient access to regulated and controlled documents by users.• Collaborated with scientists to update and revise SOPs and Manuals.• Documented and stored SOPs and Manuals into a catalogued system.• Archived, reconciled and inventoried current and outdated SOPs and Manuals.• Created and maintained procedural layout and spreadsheets using Microsoft Excel and Word.• Provided all aspects of document control and archiving support Show less