IFB Documentation management Lead

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 ? The race is on to design & build our new fully greenfield Insulin flex facility in Beijing addressing production capacity demand.

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 IFB 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 set-up documentation management tool for IFB (Kneat / GEDMS / QualiPSO)

• To lead the IFB 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 within Sanofi IFB project organization.

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

• To ensure all team-mates from IFB 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.

• 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.

• Very good knowledge of documentation management in major pharmaceutical capex project.

• 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.

Soft skills:

• Very good communication and presentation skills

• Systematic and structured work style

• Result oriented and pragmatic

Technical skills:

• Good knowledge of FDA/EMA and other regulatory requirements such as cGMP about documentation.

• Knowledge and experience in using QualiPSO (Veeva), Meridian EDMS and Kneat digital tool to manage quality and standard document, engineering and project document and C&Q document.

• Good general technical knowledge, ability to interact with experts.

Education:

• Good general technical knowledge, ability to interact with experts.

Languages:

• Good general technical knowledge, ability to interact with experts.

Why choose us ?

• Play an instrumental part in creating best practice within our manufacturing facility.

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact 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 identi