Specialist I, Quality Systems

Job title: Specialist I, Quality Systems

Location: Singapore

Hiring Manager: Senior Manager, Quality Systems

About the job:

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.

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: “Sanofi will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+”.

In this context, we are looking for a Specialist I, Quality Systems for our new site based in Singapore.

Main responsibilities

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

• The Specialist I, Quality systems will be responsible for maintaining the Document Management Processes to ensure that they meet Sanofi global quality standard requirements and fulfil the applicable regulatory expectations.
• Serves as an expert for documentation systems (electronic and paper) to assist the site departments in their assessment and implementation of the documentation management and control processes. This will ensure compliance to the site documentation system.
• Provide support to the site Business Process Owner for Document Management System
• Quality oversight of the EVF SG Document Management, monitor the overall health and efficiency of the entire EVF SG Document Management to ensure robustness and identify improvement opportunities.
• Implement document management processes such as issuance and archival of GMP records and logbooks.
• Support operational readiness to ensure overall success of the EVF project lifecycle and during routine operations.
• Provide support for Quality oversight of Learning Management System and site training procedures as business Quality representative.
• Support QMS related trainings and coaching for the Quality organization.
• Monitor the setting up of the site learning curricula for the site departments, ensuring the curricula remain up to date with GxP requirements and meet the required training needs of the learners.
• Monitor the GxP performance metrics for training and working with site departments to close any gaps or to improve performance.
• Support implementation of key Quality Systems (e.g. QMS, Defects, Recall, CAPA, Deviation) to ensure that they meet Sanofi global quality standard requirements and fulfil the applicable regulatory expectations.
• Support inspection readiness activities and active participation in providing support during external regulatory audits.
• Provide support for development and roll out of Quality Culture Programs on site.
• Contribute to reach the EVF quality manufacturing 4.0 ambition.

About You

Education and experience

• Bachelor’s Degree in Sciences, engineering or other related technical field. 
• Minimum of 2 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.
• 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 necessary partnerships for successful execution of job responsibilities.
• Excellent verbal and written communication skills and presentation skills across different levels of the organization.