Global Quality Operations Representative tasks include:



Partner with and support assigned functional groups, departments, and regions to achieve the goals and objectives of the Global Quality Team



Interact with the various business groups within the Global Quality team and support their technology needs by partnering with IT to implement solutions that support their functions.



Plan and execute Change Management activities to ensure successful completion of technology and process improvement initiatives.



Maintain ongoing communication with relevant stakeholders for project-related activities and tasks that support the Global Quality team.



Work with key stakeholders from the Global Quality team to ensure training plans and materials are created for new systems and change requests.



Represent the interests of the Global Quality team to identify solutions for their process improvement needs and their technology needs.



Work with the Global Quality team to gather and document requirements to provide solutions to support their needs.



Support the Global Quality Operations team to identify new solutions for existing challenges and establish a roadmap to drive process improvement and digital transformation.



Partner with project teams and relevant stakeholders on business systems identification, validation, implementation, control, and continuing enhancement to achieve business objectives.



Provide frontline business input support for requirements on processes, tools, implementations, and change management activities.



Ensure thorough review and/or approval of Global Quality validation/qualification documentation, plans, reports, and other documentation, as applicable.



May act as Quality Trainer for assigned processes, tools, and software, as applicable.



May act as Quality Representative for project information dissemination to internal stakeholders, alliance partners, and other company vendors, as applicable.



Qualifications/ Required



4-5 years of IT Quality or Quality System related experience is required.



Ability to Influence stakeholders across functions.



Ability to build partnerships with other functional leads



Ability to work effectively in a matrixed, multi-cultural, collaborative, and self-directed environment.



Advanced analytical skills, and general understanding of the drug development and regulatory process is required.



Knowledge of GxP areas



Knowledge of Computer System Validation



Exceptional oral and written communication skills



Experience with software applications that will be regularly used (in particular: Excel, MS Project, SharePoint, PowerPoint, and MS Teams).



Experience/ Preferred



Quality Systems in a pharmaceutical company, GxP experience



Experience demonstrating solutions-based approaches for quality system related issues



Demonstrated contributions that have helped innovatively transform processes, technology, roles, organizational activities, and collaborations.



Working knowledge of 1 or more of the following systems

Quality Management System (Trackwise/ Trackwise Digital preferred)



Document Management System (Veeva Quality Docs preferred)



Learning Management system (ComplianceWire preferred)



Educational Qualifications



BS/MS degree in Computer Science, Information systems, or related scientific discipline.