Global Quality Documentation Senior Specialist

• ​Location: Budapest

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.

Main responsibilities

• Execute administration and governance related tasks:
• Identify opportunities for document format improvement: Format monitoring for alignment with global strategy
• Identify opportunities for process improvement: interaction with global doc team, and support to global doc strategies
• Manage stakeholder list to be used for review and distribution
• With a focus on initiation of quality documents (QD) workflow management: share all information needed: Identify authors, applicable templates sharing, document change request (DCR) communication, Standard (STD)/requirement information sharing,  draft generation in QualiPSO (ID, metadata creation), reformatting and final draft cleanup before approval
• Management and monitoring of documentation update priorities
• Coordinate corporate STD/GOP gap assessment with external liaison team (against regulation): material preparation, support between EL & BPO as well as monitoring
• Support global quality documentation team and global experts: Q&A redirection on doc content to experts: Direct questions to the appropriate authors and subject matter experts (SMEs) and providing expert responses, first level answer for questions related to documentation process, data extractions, report generation, questions about QualiPSO metadata
• For transversal Content Management System (CMS) QualiPSO administration, provide good documentation practices training
• Support document change request (DCR) process – Monitoring of DCR process including pre-assessment and support doc update according to change request process
• Management a weekly communication on Global Quality Document approval, and generate QualiPSO extraction on demand
• Support the QualiPSO CMS BPO in the implementation of technical changes and process improvements

Experience: 

• Approximately 3 years of professional experience in documentation, in GxP environment  

Soft and technical 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
• Agile thinker and learner, adaptable to complex & dynamic environments
• Strong skills in Quality DMS, Word, Excel, PowerPoint

Education: Minimum bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field

Languages:

• Excellent written and verbal communication skills in English

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Work from an "Office of the Year 2023" award winner with flexible home office policy
• 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, Summer Events, Well-Being Lectures & Sport Clubs)

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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

Sector(s):

• Manufacturing, Production
• Quality Assurance
• Business Supporting Centres
• Client Support, Administration

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