Documentation Control Lead IFF (all genders) - Inklusiver Job - - -

Sanofi-Aventis Deutschland GmbH; Frankfurt; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

Sanofi is seeking a seasoned documentation manager for a significant pharmaceutical capex project, where you'll lead all documentation management activities from engineering to qualification. Your expertise will ensure compliance with global standards and enhance project delivery in a complex matrix environment.

Qualifikationen

• Several years of experience managing teams in the pharmaceutical industry.
• Proven multi-year experience in project and engineering management.
• Excellent communication and presentation skills.

Aufgaben

• Lead the IFF documentation management.
• Design a detailed approach for document management.
• Coordinate work with engineering contractors and Sanofi IFF organization.

Kenntnisse

Communication

Project Management

Documentation Management

Team Management

Ausbildung

PhD, Master's degree, or diploma in engineering or natural sciences

Jobbeschreibung

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About the job

Are you ready to jump into a mega project (> 1 B€ Capex program, including 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 the end of Qualification activities, in accordance with EHS, Quality, Engineering, Business & Users requirements, standards, and expectations. Within the IFF project team, and as 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 :

• Lead the IFF documentation management.
• Design a detailed approach to manage all documents, based on endorsed strategy on tools and processes.
• Coordinate the documentation management work with the EPCMCQ engineering contractor and all disciplines within Sanofi IFF organization.
• Ensure all documents are managed, identified, and stored as per project and global Sanofi procedures.
• Train and inform team members from the IFF team and EPCMCQ contractor about documentation management.
• Lead and manage CTOP / VTOP / ETOP preparation and turnover from vendor/contractor/engineering contractor to C&Q team, and then hand-over between C&Q team and user / ICF.
• Support project change, engineering change, and technical change assessments related to documentation management.
• Collaborate on project meetings.

About you

• Experience: Several years of professional experience managing teams (direct and indirect) in the pharmaceutical industry; strong experience in pharmaceutical documentation management; proven multi-year experience (> 10 years) in project and engineering management; experience working in large, complex matrix environments with global processes and governance structures; excellent 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 concerning documentation; very good knowledge of documentation management in major pharmaceutical capex projects.

Education: PhD, Master's degree, or diploma in engineering or natural sciences.

Languages: Very good English and German language skills, both written and verbal.

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