Job Information

Sanofi Group Cadre Assurance Qualité BPF in Montpellier, France

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

This job offer is accessible to all, regardless of gender.

About the Role

This position is responsible for implementing and monitoring the quality assurance system within the GMP Operations sectors of the Synthetics Scientific Platform and Quality Control in Montpellier, ensuring compliance with current regulatory standards including Good Manufacturing Practices (GMP).

Key Responsibilities:

Operational Quality Assurance

Represent Quality Assurance within:

  • Analytical Sciences Department

  • Physico-chemical laboratories (Quality Control)

  • Pharmaceutical Sciences Department

Audit and approve:

  • Manufacturing Masters and Technical Conditions

  • Manufacturing batch records for GMP Operations sector

  • Oversee bulk product manufacturing (primarily oral forms) conducted internally or externally

  • Draft Quality Agreements for manufacturing subcontractors

  • Participate in preparing regulatory authority inspections

  • Coordinate and evaluate investigations following anomalies and/or process deviations

  • Approve Change Controls in dedicated IT applications

  • Draft, review and approve operating procedures

  • Conduct self-inspections and external audits

  • Deliver Quality training

  • Initiate and/or participate in quality improvement projects

  • Participate in lot recalls in collaboration with involved departments

QP Release

  • Perform release of investigational medicinal products (bulk products)

Project Support

  • Serve as Quality representative in CMC Synthetics project teams for assigned projects

About you

Qualifications:

Education

  • Doctorate in Pharmacy required

Experience

Experience in pharmaceutical development and/or Quality Assurance, including:

  • Operational Quality Assurance

  • Project Quality representative

  • Batch release

  • CMC activity or CMC quality monitoring

Required Skills

  • Mandatory Qualification: Doctor of Pharmacy degree

  • Proficiency with IT tools

  • Experience working in cross-functional projects or missions

  • Fluency in both written and spoken English necessary for the role

Knowledge Areas

  • Good understanding of GxP regulations

  • Knowledge of Pharmaceutical Development processes

  • Experience with subcontracting management

Pursue Progress . Discover Extraordinary .

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, 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) !

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) !

Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)

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)