Job title: User Acceptance Testing Specialist

Grade: L2-2

Hiring Manager: Krista Kuczynski, Michael Barth

Location: Budapest, Hungary

Flexible working: 60% home, 40% office

Job type: Permanent, full-time

About the job

We are currently on a journey where we are transforming how we support our Global Regulatory Affairs (GRA) teams and are looking for team members who can join us on this exciting journey.

As a member of User Support Regulatory Operations , the User Acceptance Testing (UAT) Specialist is responsible for oversight of UAT activities and will contribute to the vendor process and service improvement.

This person will be a key member of a highly productive team, a collaborative team player, and will work very closely with colleagues in Global Regulatory Operations (GRO).

• Perform User Acceptance script writing and execution for the GRA owned technology projects.
• Collaborate with the Business Process & Innovation group for the script writing function, validation strategy and design.
• Collaborate with ITS colleagues for the validation function.
• Support internal audits and regulatory inspections by providing appropriate user acceptance documentation for the GRA owned technology.

• Functions as the primary point of contact for UAT script writing and execution.
• Ensures UAT strategy aligns with GRA system capabilities, BCP, and user experience.
• Partners with the Business Process & Innovation group and the ITS Validation Lead to assess the EMA and FDA regulations and ensures the UAT function is in synch with regulations and guidelines.
• Establishes quality compliance to script writing with tests aligned with role, functionality, architecture, and testing.
• Ensures documentation to support these processes are in place and current.
• Ensures UAT scripts are written and executed in a controlled state and follow good validation methodology and documentation practices.
• Leads the vendor UAT team. Ensures that the team is operating in a harmonized and efficient manner.
• Provides operational strategy and direction to the vendor team.
• Collaborates with external personnel to provide UAT support for Veeva and integrated platform.

• Ability to lead multi-disciplinary and global teams and interface with upper-level management of support and client organizations.
• Process oriented with knowledge in Operational excellence.
• Experience in problem-solving techniques.
• Knowledge and experience in implementing operational metrics, process improvements.
• Knowledge of Regulatory Affairs/Operations domain and regulatory requirements is desirable, however, not essential.

• Ability to embrace new activities and willingness to learn.
• Strong interpersonal and collaboration skills.
• Ability to work with multifunctional and multicultural teams.
• Collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness.
• Keen verbal and written communication skills.
• Excellent attention to detail.
• Ability to manage multiple and shifting priorities efficiently, self-motivated.
• Ability to propose solutions and efficiencies. Demonstrated continuous improvement mindset.
• Ability to maintain discretion and confidentiality about sensitive data.
• Dedicated and persuasive "can-do" attitude and entrepreneurial spirit.
• Knows when sufficient data has been collected to solve a problem.
• The ability to understand the great importance of database accuracy.
• Ability to communicate in English (verbally and written) effectively and efficiently across varying functions and levels of management.

• Working knowledge in Microsoft Office and Windows (Outlook, Word, Excel, PowerPoint).
• Knowledge of Validation methodology, strategy, testing, documentation requirements and CFR Part 11 to support the validation of computer systems.
• Veeva VAULT RIM and Business Objects Universe design, creation, testing and technical skills a plus but not required.
• Regulatory Information Management knowledge is a plus but not required.

• Minimum of a BSc degree in scientific, IT or engineering.

• Excellent written and verbal communication skills in English.

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
• An attractive, market-oriented salary and cafeteria benefits.
• Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days.
• Work from an "Office of the Year 2020" finalist office.
• Collective life and accident insurance.
• Yearly medical check-up.
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks.
• Your own career path within Sanofi. Your professional and personal development will be supported purposefully.
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs).