Regional Quality Documentation Senior Specialist (fixed term)

Job description

+ Job title: Regional Quality Documentation Senior Specialist
+ Location: Budapest, Hungary
+ Job type: Fixed-term 1 year contract, full time
+ Hybrid working

**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.

**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.
+ At least 1 year experience in GxP environment.

**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

**Languages** :

+ Excellent English communication and writing
+ Proficiency in at least one of the listed languages: French, German, Italian, Spanish, Russian, Hungarian, Turkish.

**Why choose us?**

+ 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)

**Pursue** _Progress_ .

**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.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Discover our Code of Conduct (https://www.codeofconduct.sanofi/) , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives.

Please ensure to have read this document before applying.

#Sanofi #SanofiCareers #joinSanofi

#jobopportunities #careeropportunities #sscjob

#Sanofi_Budapest_Hub #Budapest

#R&D

#LI-EUR #LI-hybrid

**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 or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)

Sanofi is dedicated to supporting people through their health challenges.

We are a global biopharmaceutical company focused on human health.

We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering.

We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life.

We are constantly moving and growing, making sure our people grow with us.

Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)

Required Skill Profession

Other General