Digital Quality System Management - PQR

• 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).

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

• 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 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.

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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!