• Store, manage and track company documents and data.• Develop, implement, and maintain procedures to comply with Airspace guidelines.• Maintain configuration control of all controlled documented information.• Train employees on record management procedure and policies including destruction and disaster recovery.• Assist with file migrations and audits.• Perform administrative tasks as needed.• Follow ISO9100, AS9100, ITAR.

• Maintain Quality Management Systems and Electronic Document Management System to assure compliance and effectiveness. • Support the management of Controlled Documents, manage the training program, onboard new employees, data management and archival.• Prepare and distribute quality metric reports. • Create and maintain templates for controlled documents. • Support Regulatory submission and on-going regulatory compliance in support of product development.• Follow 21 CFR Part 11 Compliance.

• Administrate the process and practices which support documentation compliance• Support the management of Controlled Documents, publish TOCs, word processing of reports and standard operating procedures• Log, track, and maintain status of documents• Upload documents into the correct document control system• Maintained and reviewed for completeness of training databases (kept in Excel)• Ensured CAPAs and audit observations were followed up toward successful closure

• Work with program managers, to develop and maintain project plan including timelines/ milestones, budgets and resources• Provide project management support to core and sub teams, including meeting agenda, meeting minutes and action items, as needed.• Provide support to program managers in completion of all required tasks to meet goals such as First Patient In and other study related timelines.• Create and maintain plans within MS Project/SmartSheet and communicate project status in designated forums.

• Supported Project Management, including project definition, workstream identification, scope and resource definition, artifact creation to include project plan, document repository, milestones, and status reports, project execution, status meetings, and final leadership review for 11 divided projects.• Project Managed for team to align multiple software programs to make more efficient between multiple Product Development groups. Created agenda and minutes.• Provide extensive day - day executive support to the Vice President of Immunology, Infectious Disease and Ophthalmology, Safety Risk Management, his direct reports and their teams; provide executive support for visiting Global Head of PDS and Global Head of Safety Science.• Effectively manage heavy meeting and event calendars; Coordinate, schedule, and prepare for meetings, including agendas and minutes; demonstrate discretion with sensitive and confidential information.• Successfully plan on - and off-site face to face events in the US and Internationally; venue and logistics coordination; ensuring budget stays on track.• Organized Product Development Career Fair, negotiated contracts, managed crew for set-up and take down of floor plan, created purchase orders, designed and formatted banners, collaborated with career lab to have career coaches attend while remaining within the financial budget for the project.• Regularly apply proficiency in Microsoft Word, Excel, PowerPoint, Visio, Microsoft Project, and gMail.