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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.

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)