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).

About Growing with us

Main responsibilities

The User Acceptance Testing group’s mission is to:

• 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.

Primary areas of responsibility include:

• 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.

About you

Knowledge, Skills & Competencies

Experience:

• 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.

Soft skills:

• 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.

Technical skills:

• 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.

Education:

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

Languages

• Excellent written and verbal communication skills in English.

When joining our team, you will experience:

• 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).

Pursue progress. Discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!