Quality Documentation Project Manager (Project mode) M/F

Job description

CONTEXT

In a global evolving pharma industry, Sanofi is creating a major leading European company dedicated to the production and marketing to third parties of active pharmaceutical ingredients (API), which are the essential molecules responsible for the beneficial effects used in the composition of any drug. The project consists of creating a standalone company which would combine Sanofi’s API commercial and development activities with six of its European API production sites: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France).

With increasing medicine shortages that critically impact patient care, the new entity would contribute to supporting and securing API manufacturing as well as supply capacities for Europe and beyond. In Europe, the new API industry champion is expected to help in balancing the industry’s heavy reliance on API sourced from the Asian region.

The ambition of the new company is to be the world's second largest API company with approximately €1 billion in expected sales by 2022. It is expected to include 3,100 skilled employees and to be headquartered in France.

( please visit: https://www.activeingredientsolutions-sanofi.com/en for more info.)

PURPOSE OF THE POSITION

       

·  Manage corporate quality documents to enhance compliance with applicable regulations in line with the quality strategy for his domain of expertise
·  Deliver the necessary expertise to ensure proper management of the Global Quality Documentation and training System.
·  Compilation of corporate quality documents in the computerized Documentation Management and Learning Management Systems (Documentum/iLearn or equivalent)
·  Administration, maintenance and deployment of new features of company DMS / LMS systems.

Knowledge / experience / expertise in the field of:

·  Knowledge about Good Manufacturing Practices (GMP) based on ICH, EU GMP, US CFR, WHO
·  Quality Management System (QMS)/QA/QC related processes and GxP applicable regulations
·  Knowledge of computerized Document Management and Learning Management Systems (DMS / LMS)

MAIN RESPONSIBILITIES

·  Manages a portfolio of Corporate Quality Documents and Standard Operating Procedures, as appropriate, to be created or revised in his/her area of expertise.
·  Drafts the Corporate Quality Documents in the established templates, considering the requirements are in accordance with GMP regulations, company quality policy, maintaining agreed terminology (global quality glossary) and are oriented for  effective and practical support to operations.
·  Coordinates with the sites and subject matter expert (SME) for review of the draft documents, collection of feedback and compilation.
·  Contributes to the life cycle of the Quality documents in the computerized management system.
·  periodic review of some global quality documentation planning
·  change requests related to some global quality documentation
·  review process for some global quality documentation.
·  Be a Key User of the Documentation Management and Learning Management Systems and participates to their use and deployment in operational sites / entities.
·  Creates and maintains a training package for the quality documents if applicable, and is capable of providing training support within operations
·  Ensures the quizzes associated to the ‘Read & Understand’ module are developed or updated with the authors after a new or revised document is made effective, if applicable.
·  Acts as an administrator for Documentation Management and Learning Management Systems to maintain Master Data according to the defined company Core Model.
·  Compiles queries from Quality (including support during inspections), ITS stakeholders, Operation for any topics related to documentation management and IT related applications.

Dimension (ex. : Budget, number of headcount to manage)

·  No direct reports
·  The role ensures transversal interactions with the different entities of the group (Quality functions, Operations, IT, …)
·  The role holder has strong compliance mindset, is results-driven, can-do-attitude.
·  The role ensures computerized skills for documentation management & learning management system.

Diploma Level / Experience

·  Chemistry, Engineer
·  + 3 years in Pharma/API industry

Technical skills &

Specifics Knowledges / Language

·  Exposure in Quality Management system
·  Knowledge in Regulatory requirements, specifically pharmaceutical drug Regulations, e.g. FDA and EMA regulations, GMP, Pharmacopeia, ICH
·  Knowledge of working of different functions like QA/QC/production/ distribution/ITS/...)
·  Foreign language (English) is a Must

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.