Job Description

Mission

Sanofi is preparing its future through an ambitious program named Evolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi Pasteur strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges. Digital will be one of the key topics to help EVF to reach its ambition. On top of it, Sanofi is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: \xe2\x80\x9cSanofi will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+\xe2\x80\x9d.

In this context, we are looking for one Quality System Expert (Documentation & Training) for our new site based in Singapore.

Key Accountabilities

The mission described below, must be exercised in compliance with health, safety and environment of the site rules.

The QMS Expert will be responsible to develop and implement robust Document Management Processes to ensure that they meet Sanofi global quality standard requirements and fulfil the applicable regulatory expectations.

Partner with the Learning Enablement team to establish the competency-based learning (CBL)\xe2\x80\x8b program for the site to ensure that it meets Sanofi global quality standard requirements and fulfils applicable regulatory expectations.

Business Process Owner for Document Management System

Responsible for Quality oversight of Learning Management System and site training procedures as business Quality representative

Support operational readiness to ensure overall success of the EVF project lifecycle and during routine operations.

Responsible and owns the site Document Management procedures.

Responsible for Quality oversight and to monitor the overall health and performance of the entire EVF SG Document Management to ensure robustness and identify improvement opportunities.

Lead and support QMS related trainings and coaching for the Quality organization.

Define and maintain competency mapping document for Quality organization, as well as for quality-related trainings to be assigned to specified target audience.

Author site-specific CBL training packages related to Document Management and deliver relevant associated training, as required.

Lead and develop strategies/playbooks for Document Management related topics to ensure successful regulatory inspections and site audits.

A key EVF SG QMS representative to partner and collaborate closely with cross functional teams to achieve the EVF SG site operational goals/objectives.

Education and experience

Bachelor\xe2\x80\x99s or Master\xe2\x80\x99s Degree in Sciences, engineering or other related technical field.

Minimum of 8 years of relevant experiences preferably in Manufacturing, Validation, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics).

Key technical competencies and soft skills:

Manufacturing 4.0 mindset (such as Agile methodology)

Knowledge of regulations and standards of the pharmaceutical industry and Global Quality policies.

Solid knowledge of Quality Management Systems and associated technologies, particularly in the areas of Document Management.

Good understanding of GMP training.

Strong interpersonal relationships in order to establish the partnerships necessary for the development of an engrained Quality culture.

Demonstrated past success to lead QMS processes implementations.

Excellent verbal and written communication skills and presentation skills across different levels of the organization.

Experienced in facility start-ups will be advantageous.

Experience in working internationally and cross-functionally.

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.

Sanofi