Digital Quality System Management - PQR

Reposted 15 Days Ago
Be an Early Applicant
Budapest, HUN
In-Office
Mid level
Healthtech
The Role
Manage and implement digital quality solutions while ensuring compliance with quality standards in pharmaceutical manufacturing and supply chain processes. Lead projects, support user adoption, and ensure effective use of digital tools across organizations.
Summary Generated by Built In
  • Job title: GenAIR PQR Expert

  • Location: Budapest, Hungary

  • Hybrid working (60% office, 40% home)

  • Job type: Permanent, full time

About the job

Within PTSO organization, the Quality Programs team is responsible to ensure the successful & compliant design and implementation of Quality Digital solutions supporting the strategic transformation of Quality operations, towards simplified, standardized & digitized processes. Our team is responsible to lead the quality digital transformation, managing digital projects and quality data. The scope includes all projects within the quality global function: Quality Management Systems, Quality control, Supply Chain & manufacturing as well as Analytics related projects.

This includes the ownership of the solution and relative data for the Quality Function: structure and maintenance of the global quality data referential (QA/QC) and to advise on it’s appropriate and consistent usage across digital projects and processes. It covers KPIs & artificial intelligence use cases for Quality.

Main responsibilities:

In the frame of Quality transformation & digitalization, contribute to the execution of Digital Projects as Business expert in agile mode, including accountability for appropriate & compliant design of simplified and standardized processes defined by relevant Business Process Owners, manage planning, quality of the delivery, compliance, and excellence in execution at shopfloor level (site, affiliate, entity).This also includes compliance of the digital solution upon design, deployment and all along life cycle management.

Under the supervision of the Global Solution Lead, and the umbrella of the program lead, contribute to the delivery (build, deploy and support to routine usage) of M&S Quality digital capabilities (related to serialization, secured Batch release & shipment to Market, eBatch release protocol towards heath authorities,Batch traceability & genealogy, digitalized forms at shopfloor manufacturing & warehousing).

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.

Project execution (design, test and implementation):

  • Contribute to project execution & successful delivery of compliant global digital quality solutions for Global Quality in alignment with the defined strategy and process designed (adherence to prescribed process, user stories scripting, risk assessment, UAT scripting & execution, defect management, training material delivery, user adoption & support along life of the system)

  • Contribute to the implementation of a clear and consistent approach to manage project risks, progress and delivery

  • Ensure close collaboration with digital teams & partner solutions / teams as needed

Support deployment & Quality processes transformation

  • Support the transformation of processes and ways of working associated with the project under his/her responsibility.

  • Contribute to user adoption, and support end users in daily operations (trouble shooting, escalation of quality events…)

  • Coordinate and ensure consistency of usage (across organizations/GBUs) in adequation with real needs and process design

  • Ensure Life cycle management & compliance along time (deviation management, incidents solving, change control, etc..) in liaison with BPOs, Global Solution business owner and digital teams

  • Contribute to value realisation through the implementation & usage of the new solution implemented

  • Support measurement of the impact of the solution implementation through relevant KPIs defined with Performance team and the relevant BPOs

About you

Experience:

  • Manufacturing & supply shopfloor processes knowledge & experience (Product Quality Review writing)

  • Significant experience in digital projects in agile mode and in pharmaceutical Manufacturing, Supply chain and Quality areas

Technical skills:

  • Pronounced appetite for digital & data

  • Solid knowledge & experience of computerized systems GxP requirements & validation and in Data Integrity

​​Soft skills

  • Team player

  • Rigorous in an agile working environment,

  • Ability to communicate, deliver & report

  • Action & result oriented

Education:

  • Technical or scientific education

Languages:

  • Good level of Professional English

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, Summer Events, Well-Being Lectures & Sport Clubs)

Office of the Year 2025 – Evolution Award
Our most recent award – Sanofi is recognized for creating an innovative workspace that supports collaboration and adaptability.

Marketing Diamond Award 2026 – Employer Branding
One of the highest honours at Hungary's prestigious Marketing Diamond Awards, recognizing excellence in employer branding.

BSC Investor of the Year 2025
Awarded by HIPA, ABSL Hungary, and AmCham Hungary for our contribution to Hungary's business services sector.

PwC Workforce Preference Survey 2025 – Top 3 Most Attractive Employers
Ranked 3rd among the most attractive employers in Hungary.

Hungarian Employer Branding Awards 2025 – Gold & Silver
Best Strategic Employer Branding Campaign (Gold) and Best Employer Branding Campaign in the Pharma Sector (Silver).

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

Discover our Code of Conduct, 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

#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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

The salary range for this position is :Ft10 944 000,00 - Ft16 416 000,00

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.

Skills Required

  • Experience in manufacturing and supply shopfloor processes
  • Experience in digital projects in agile mode within pharmaceutical manufacturing, supply chain, and quality areas
  • Knowledge and experience of GxP requirements and validation of computerized systems
  • Strong communication and problem-solving skills
  • Technical or scientific education

Sanofi Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sanofi and has not been reviewed or approved by Sanofi.

  • Retirement Support Retirement support stands out through a notably strong 401K matching structure (e.g., 150% match up to a 6% contribution), which materially boosts total rewards for long-tenured employees.
  • Parental & Family Support Parental and family support is positioned as unusually robust, including a global gender-neutral paid parental leave standard (14 weeks) and added supports such as childcare assistance and adoption/surrogacy/infertility help.
  • Equity Value & Accessibility Equity participation is made more accessible via an Employee Stock Purchase Plan that includes a meaningful purchase discount and matching/free-share mechanics, increasing perceived total compensation beyond base pay.

Sanofi Insights

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The Company
HQ: Paris
85,000 Employees
Year Founded: 1973

What We Do

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms

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