Documentation Control Lead IFF (all genders) - #2216929

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About the job

Are you ready to jump into a mega project (> 1 B€ Capex program, thereof design/engineering budget >>200 m€), and to bring in your experience & knowledge ?

Your skills could be critical in helping us to achieve our key project milestones. You will lead all Documentation management activities from Basic Engineering until end of Qualification activities in accordance with EHS, Quality, Engineering, Business & Users requirements standard and expectations. Within the IFF project team, and part of our InsuLINK program for insulin drug substance facilities.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams.

With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main responsibilities:

• To lead the IFF documentation management.

• To design detailed approach to manage all documents, based on endorsed strategy on tool and processes.

• To coordinate the Sanofi documentation management work with the EPCMCQ engineering contractor for the documentation management topic and all disciplines withing Sanofi IFF organization.

• To ensure all documents are managed, identified and stored as per project procedure and global Sanofi procedures.

• To ensure all team-mates from IFF team and from EPCMCQ contractor are trained and informed about documentation management

• To lead and manage CTOP/VTOP/ETOP preparation and turn-over from vendor/contractor/engineering contractor to C&Q team, and then hand-over between C&Q team and user/ICF.

• To provide support to project change, engineering change and technical change assessment with regards to documentation management part.

• To collaborate to project meeting.

About you

• Experience: Several years of professional experience in managing teams (direct and indirect) in the pharmaceutical industry; Strong experience of pharmaceutical documentation management; proven multi-year experience (>10 years) in the area of project and engineering management; Experience in working in a large, complex matrixes environment with global processes and governance structures; Very good communication and presentation skills; Systematic and structured work style

• Soft and technical skills: Good knowledge of FDA/EMA and other regulatory requirements such as cGMP about documentation; Very good knowledge of documentation management in major pharmaceutical capex project

• Education: Phd.; Masters degree or diploma in engineering or natural science

• Languages: Very good english and germanlanguage skills, both written and verbal

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!

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!

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