Regional Quality Documentation Specialist

About the job

Our Team:

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.

Be part of something exceptional. Our Budapest Hub has been recognized for workplace excellence, innovation, and our commitment to putting people first. See the full list of our awards at the end of this posting.

Main responsibilities:

• Focus on initiation of quality documents (QD) workflow management: Identify authors, applicable templates sharing, document change request (DCR) communication if applicable, draft generation in QualiPSO (ID, metadata creation), final draft cleanup before approval.
• Manage and monitor the documentation update process, with periodic review process, in support to local document governance.
• Participate to local document governance meetings.
• Coordinate and prevent gap assessment process from other non-standardized approach.
• Manage the creation and update of metadata, understand the applicability of the documents/stakeholders, challenge the stakeholders, & implement communication strategy based local doc governance.
• Support document change request (DCR) process – support monitoring DCR process including pre-assessment & support doc update according to CR process.
• Prevent Change Request process from other non-standardized approach.
• Support communication on Global Quality Document approval.

About you

Experience:

• Professional experience in documentation.
• Experience in GxP environment is an advantage

Soft skills:

• Proficient in problem-solving.
• Attention to detail, and good organizational skills.
• Ability to work collaboratively with cross-functional teams in a flexible and proactive manner.
• Strong analytical skills.

Technical skills:

• Microsoft Office
• Strong analytical skills.
• Knowledge of Quality DMS, is an advantage.

Education:

• Bachelor’s or Master’s Degree in life sciences

Languages:

• Excellent English communication and writing

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
• 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
• Join a great community & special events (Monthly Board Game Nights, Well-Being Lectures & Sport Clubs)